Mitral Valve RegurgitationCLASPNCT03170349
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
A study testing Mitral Valve Repair in people with Mitral Valve Regurgitation, run by Edwards Lifesciences at 17 sites in 7 countries.
Trial summary
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Mitral Valve Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 27 Jun 2017to 27 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated IRB/ethics committee approved study consent form prior to study related procedures
- Eighteen (18) years of age or older
- New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy
- Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation
- Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
- The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant.
- Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable.
Who cannot join
- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
- Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation.
- Mitral valve area (MVA) < 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment
- Patient is under guardianship
Trial locations and contacts
17 sites in 7 countries.
17 sites in 7 countries
United States8 sites
University of Colorado Denver
Aurora, Colorado, 80045
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia Health System
Charlottesville, Virginia, 22908
Henry Ford Hospital
Detroit, Michigan, 48202
NorthShore University HealthSystem
Evanston, Illinois, 60201
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Morristown Medical Center
Morristown, New Jersey, 07960
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Canada3 sites
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
St Michael Hospital
Toronto, Ontario, M5B-1W8
St. Paul's Hospital, Providence Health Care Research Institute
Vancouver, British Columbia, V6E 1M7
Australia2 sites
Metro North Hospital & Health Service, The Prince Charles Hospital
Brisbane, Chermside, QLD 4032
Sydney Local Health District, Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Germany1 site
Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie
Bonn, 53127
About this study
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
Read the detailed description
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes study.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Mitral Valve Repair
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral Valve RepairDevice
Minimal Invasive Transcatheter Mitral Valve Repair
| Study group | Role | What they receive |
|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Experimental | Not described Receives: Device: Mitral Valve Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Adverse Events (MAE)
Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 30 days post-implant. MAEs during the first year of post-implant follow-up were adjudicated by a Clinical Events Committee of independent heart specialist physicians.
Measured: 30 days
Device Success
Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
Measured: Exit from the cardiac catheterization laboratory
Number of Participants With Procedural Success
Device success with evidence of mitral regurgitation reduction to ≤ 2+ (mild-moderate) at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.
Measured: through discharge
Clinical Success
Procedural success with evidence of MR reduction to ≤ 2+ (mild-moderate) and without MAEs at 30 days. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.
Measured: 30 days
Secondary outcomes (62)
Mitral Regurgitation Reduction
Mitral regurgitation (MR) severity at 30 days, 6 months, 1 year and annually thereafter. Mitral regurgitation reduction was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.
Measured: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
All-cause Mortality
All-cause mortality at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative deaths at each time point.
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 Years
Recurrent Heart Failure Hospitalization
Recurrent heart failure hospitalization at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative heart failure hospitalizations at each time point.
Measured: 30 days , 6 months, 1 year, 2 year, 3 year, 4 year
Reintervention Rates for Mitral Regurgitation
Reintervention rates for mitral regurgitation at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative reintervention rates at each time point.
Measured: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year
Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications.
Composite of major adverse events (MAEs) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 6 months, 1 year and annually thereafter. The outcome is analyzed as the count and percentage of participants with events at each timepoint.
Measured: 6 months, 1 year, 2 year, 3 year, 4 year
LVEDV by Study Visit
Left ventricular end diastolic volume (LVEDV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in LVEDV, Baseline to 6-Month Visit
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 6 Months
Change in LVEDV, Baseline to 1-Year Visit
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 1 Year
Change in LVEDV, Baseline to 2-Year Visit
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 2 Years
Change in LVEDV, Baseline to 3-Year Visit
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 3 Years
Change in LVEDV, Baseline to 4-Year Visit
Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 4-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 4 Years
LVESV by Study Visit
Left ventricular end systolic volume (LVESV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in LVESV, Baseline to 6-Month Visit
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 6 Months
Change in LVESV, Baseline to 1-Year Visit
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 1 Year
Change in LVESV, Baseline to 2-Year Visit
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 2 Years
Change in LVESV, Baseline to 3-Year Visit
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 3 Years
Change in LVESV, Baseline to 4-Year Visit
Change in left ventricular end systolic volume (LVESV) from the Baseline to the 4-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 4 Years
PASP by Study Visit
Pulmonary artery systolic pressure (PASP) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in PASP, Baseline to 6-Month Visit
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 6 Months
Change in PASP, Baseline to 1-Year Visit
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 1 Year
Change in PASP, Baseline to 2-Year Visit
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 2-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 2 Years
Change in PASP, Baseline to 3-Year Visit
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 3-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 3 Years
Change in PASP, Baseline to 4-Year Visit
Change in pulmonary artery systolic pressure (PASP) from the Baseline to the 4-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 4 Years
6MWD by Study Visit
Six-minute walk distance (6MWD) by study visit
Measured: Baseline, 6 Months and 1 Year
Change in 6MWD, Baseline to 6-Month Visit
Change in 6-minute walk distance (6MWD) from the Baseline to the 6-Month visit
Measured: Baseline and 6 Months
Change in 6MWD, Baseline to 1-Year Visit
Change 6-minute walk distance (6MWD) from the Baseline to the 1-Year visit
Measured: Baseline and 1 Year
Change in NYHA Functional Classification
NYHA Functional Classification at 6 months, 1 year and annually thereafter. NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
Measured: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
KCCQ OS Score by Study Visit
Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS) score by study visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.
Measured: Baseline, 30 Days, 6 Months and 1 Year
Change in KCCQ OS Score, Baseline to 30-Day Visit
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS) Score from the Baseline to the 30-Day visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.
Measured: Baseline and 30 Days
Change in KCCQ OS Score, Baseline to 6-Month Visit
Change in Kansas City Cardiomyopathy Overall Summary (KCCQ OS) score from the Baseline to the 6-Month visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.
Measured: Baseline and 6 Months
Change in KCCQ OS Score, Baseline to 1-Year Visit
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ OS) score from the Baseline to the 1-Year visit. The KCCQ OS score is a validated measure summarizing a patient's overall health status based on their self-assessment of heart failure symptoms, physical limitations, social limitations, and quality of life on a 23-item, self-administered questionnaire. KCCQ OS scores range from 0 to 100, with higher scores indicating better health status.
Measured: Baseline and 1 Year
EQ5D VAS Score by Study Visit
EQ5D visual analogue scale (VAS) score by study visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.
Measured: Baseline, 30 Days, 6 Months and 1 Year
Change in EQ5D VAS Score, Baseline to 30-Day Visit
Change in EQ5D visual analogue scale (VAS) score from the Baseline to the 30-Day visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.
Measured: Baseline and 30 Days
Change in EQ5D VAS Score, Baseline to 6-Month Visit
Change in EQ5D visual analogue scale (VAS) score from the Baseline to the 6-Month visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.
Measured: Baseline and 6 Months
Change in EQ5D VAS Score, Baseline to 1-Year Visit
Change in EQ5D visual analogue scale (VAS) score from the Baseline to the 1-Year visit. The EQ5D is a validated, self-administered quality of life questionnaire including a VAS that records the respondent's self-rated health status on a graduated scale (0-100), with higher scores for higher health-related quality of life.
Measured: Baseline and 1 Year
NT-proBNP by Study Visit
N-terminal pro-B-type natriuretic peptide (NT-proBNP) level by study visit.
Measured: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in NT-proBNP, Baseline to 6-Month Visit
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 6-Month visit
Measured: Baseline and 6 Months
Change in NT-proBNP, Baseline to 1-Year Visit
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 1-Year visit
Measured: Baseline and 1 Year
Change in NT-proBNP, Baseline to 2-Year Visit
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 2-Year visit
Measured: Baseline and 2 Years
Change in NT-proBNP, Baseline to 3-Year Visit
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 3-Year visit
Measured: Baseline and 3 Years
Change in NT-proBNP, Baseline to 4-Year Visit
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from the Baseline to the 4-Year visit
Measured: Baseline and 4 Years
BNP by Study Visit
Brain natriuretic peptide (BNP) level by study visit
Measured: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in BNP, Baseline to 6-Month Visit
Change in brain natriuretic peptide (BNP) level from the Baseline to the 6-Month visit
Measured: Baseline and 6 Months
Change BNP, Baseline to 1-Year Visit
Change in brain natriuretic peptide (BNP) level from the Baseline to the 1-Year visit
Measured: Baseline and 1 Year
Change in BNP, Baseline to 2-Year Visit
Change in brain natriuretic peptide (BNP) level from the Baseline to the 2-Year visit
Measured: Baseline and 2 Years
Change in BNP, Baseline to 3-Year Visit
Change in brain natriuretic peptide (BNP) level from the Baseline to the 3-Year visit
Measured: Baseline and 3 Years
Change in BNP, Baseline to 4-Year Visit
Change in brain natriuretic peptide (BNP) level from the Baseline to the 4-Year visit
Measured: Baseline and 4 Years
Change in Tricuspid Regurgitation From Baseline
Change in tricuspid regurgitation (TR) severity grade from the Baseline visit. TR severity was graded on a 5-point scale (none/trace, mild, mild-moderate, moderate-severe, severe) by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging.
Measured: 6 Month, 1 Year, 2 Years, 3 Years, 4 Years
Mitral EROA by Study Visit
Mitral effective regurgitant orifice area (EROA) by study visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in Mitral EROA, Baseline to 30-Day Visit
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 30-Day visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 30 Days
Change in Mitral EROA, Baseline to 6-Month Visit
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 6-Month visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 6 Months
Change in Mitral EROA, Baseline to 1-Year Visit
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 1-Year visit, , measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 1 Year
Change in Mitral EROA, Baseline to 2-Year Visit
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 2-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 2 Years
Change in Mitral EROA, Baseline to 3-Year Visit
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 3-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 3 Years
Change in Mitral EROA, Baseline to 4-Year Visit
Change in mitral effective regurgitant orifice area (EROA) from the Baseline to the 4-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 4 Years
Mitral Regurgitant Volume by Study Visit
Mitral regurgitant volume by study visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in Mitral Regurgitant Volume, Baseline to 30-Day Visit
Change in mitral regurgitant volume from the Baseline to the 30-Day visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 30 Days
Change in Mitral Regurgitant Volume, Baseline to 6-Month Visit
Change in mitral regurgitant volume from the Baseline to the 6-Month visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 6 Months
Change in Mitral Regurgitant Volume, Baseline to 1-Year Visit
Change in mitral regurgitant volume from the Baseline to the 1-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 1 Year
Change in Mitral Regurgitant Volume, Baseline to 2-Year Visit
Change in mitral regurgitant volume from the Baseline to the 2-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 2 Years
Change in Mitral Regurgitant Volume, Baseline to 3-Year Visit
Change in mitral regurgitant volume from the Baseline to the 3-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 3 Years
Change in Mitral Regurgitant Volume, Baseline to 4-Year Visit
Change in mitral regurgitant volume from the Baseline to the 4-Year visit, measured using the proximal isovelocity surface area (PISA) method during independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging
Measured: Baseline and 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start27 Jun 2017
- Primary completion30 Jul 2020
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gideon Cohen, MD, Principal investigator, Sunnybrook HospitalUlrich Schafer, MD, Principal investigator, BundeswehrZentralkrankenhaus KoblenzMolly Szerlip, MD, Principal investigator, The Heart Hospital Baylor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170349
- Sponsor's protocol ID
- 2016-05
- Acronym
- CLASP
- Status last verified
- Dec 2025
- First submitted
- 26 May 2017
- Last updated
- 5 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Webb JG, Hensey M, Szerlip M, Schafer U, Cohen GN, Kar S, Makkar R, Kipperman RM, Spargias K, O'Neill WW, Ng MKC, Fam NP, Rinaldi MJ, Smith RL, Walters DL, Raffel CO, Levisay J, Latib A, Montorfano M, Marcoff L, Shrivastava M, Boone R, Gilmore S, Feldman TE, Lim DS. 1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. JACC Cardiovasc Interv. 2020 Oct 26;13(20):2344-2357. doi: 10.1016/j.jcin.2020.06.019.
PubMed 33092709Lim DS, Kar S, Spargias K, Kipperman RM, O'Neill WW, Ng MKC, Fam NP, Walters DL, Webb JG, Smith RL, Rinaldi MJ, Latib A, Cohen GN, Schafer U, Marcoff L, Vandrangi P, Verta P, Feldman TE. Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. JACC Cardiovasc Interv. 2019 Jul 22;12(14):1369-1378. doi: 10.1016/j.jcin.2019.04.034. Epub 2019 Jun 26.
PubMed 31255562
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
- ClinicalTrials.gov ID
- NCT03170349
- Acronym / sponsor ID
- CLASP / 2016-05
- Conditions
- Mitral Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Posted 1 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
Detailed description
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edwards PASCAL Transcatheter Mitral Valve Repair System | Experimental | Device: Mitral Valve Repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed and dated IRB/ethics committee approved study consent form prior to study related procedures
- Eighteen (18) years of age or older
- New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy
- Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation
- Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
Key exclusion criteria (8 listed)
- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
- Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation.
- Mitral valve area (MVA) < 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral Valve RepairMinimal Invasive Transcatheter Mitral Valve Repair | Device | Edwards PASCAL Transcatheter Mitral Valve Repair System |
Primary outcome
Number of Participants With Major Adverse Events (MAE)
Time frame: 30 days
Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 30 days post-implant. MAEs during the first year of post-implant follow-up were adjudicated by a Clinical Events Committee of independent heart specialist physicians.
Device Success
Time frame: Exit from the cardiac catheterization laboratory
Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
Number of Participants With Procedural Success
Time frame: through discharge
Device success with evidence of mitral regurgitation reduction to ≤ 2+ (mild-moderate) at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.
Clinical Success
Time frame: 30 days
Procedural success with evidence of MR reduction to ≤ 2+ (mild-moderate) and without MAEs at 30 days. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.
62 secondary outcomes
Mitral Regurgitation Reduction
Time frame: Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
All-cause Mortality
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 Years
Recurrent Heart Failure Hospitalization
Time frame: 30 days , 6 months, 1 year, 2 year, 3 year, 4 year
Reintervention Rates for Mitral Regurgitation
Time frame: 30 days, 6 months, 1 year, 2 year, 3 year, 4 year
Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications.
Time frame: 6 months, 1 year, 2 year, 3 year, 4 year
LVEDV by Study Visit
Time frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in LVEDV, Baseline to 6-Month Visit
Time frame: Baseline and 6 Months
Change in LVEDV, Baseline to 1-Year Visit
Time frame: Baseline and 1 Year
Change in LVEDV, Baseline to 2-Year Visit
Time frame: Baseline and 2 Years
Change in LVEDV, Baseline to 3-Year Visit
Time frame: Baseline and 3 Years
Change in LVEDV, Baseline to 4-Year Visit
Time frame: Baseline and 4 Years
LVESV by Study Visit
Time frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in LVESV, Baseline to 6-Month Visit
Time frame: Baseline and 6 Months
Change in LVESV, Baseline to 1-Year Visit
Time frame: Baseline and 1 Year
Change in LVESV, Baseline to 2-Year Visit
Time frame: Baseline and 2 Years
Change in LVESV, Baseline to 3-Year Visit
Time frame: Baseline and 3 Years
Change in LVESV, Baseline to 4-Year Visit
Time frame: Baseline and 4 Years
PASP by Study Visit
Time frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in PASP, Baseline to 6-Month Visit
Time frame: Baseline and 6 Months
Change in PASP, Baseline to 1-Year Visit
Time frame: Baseline and 1 Year
Change in PASP, Baseline to 2-Year Visit
Time frame: Baseline and 2 Years
Change in PASP, Baseline to 3-Year Visit
Time frame: Baseline and 3 Years
Change in PASP, Baseline to 4-Year Visit
Time frame: Baseline and 4 Years
6MWD by Study Visit
Time frame: Baseline, 6 Months and 1 Year
Change in 6MWD, Baseline to 6-Month Visit
Time frame: Baseline and 6 Months
Change in 6MWD, Baseline to 1-Year Visit
Time frame: Baseline and 1 Year
Change in NYHA Functional Classification
Time frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
KCCQ OS Score by Study Visit
Time frame: Baseline, 30 Days, 6 Months and 1 Year
Change in KCCQ OS Score, Baseline to 30-Day Visit
Time frame: Baseline and 30 Days
Change in KCCQ OS Score, Baseline to 6-Month Visit
Time frame: Baseline and 6 Months
Change in KCCQ OS Score, Baseline to 1-Year Visit
Time frame: Baseline and 1 Year
EQ5D VAS Score by Study Visit
Time frame: Baseline, 30 Days, 6 Months and 1 Year
Change in EQ5D VAS Score, Baseline to 30-Day Visit
Time frame: Baseline and 30 Days
Change in EQ5D VAS Score, Baseline to 6-Month Visit
Time frame: Baseline and 6 Months
Change in EQ5D VAS Score, Baseline to 1-Year Visit
Time frame: Baseline and 1 Year
NT-proBNP by Study Visit
Time frame: Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years
Change in NT-proBNP, Baseline to 6-Month Visit
Time frame: Baseline and 6 Months
Change in NT-proBNP, Baseline to 1-Year Visit
Time frame: Baseline and 1 Year
Change in NT-proBNP, Baseline to 2-Year Visit
Time frame: Baseline and 2 Years
Change in NT-proBNP, Baseline to 3-Year Visit
Time frame: Baseline and 3 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33092709Webb JG, Hensey M, Szerlip M, Schafer U, Cohen GN, Kar S, Makkar R, Kipperman RM, Spargias K, O'Neill WW, Ng MKC, Fam NP, Rinaldi MJ, Smith RL, Walters DL, Raffel CO, Levisay J, Latib A, Montorfano M, Marcoff L, Shrivastava M, Boone R, Gilmore S, Feldman TE, Lim DS. 1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. JACC Cardiovasc Interv. 2020 Oct 26;13(20):2344-2357. doi: 10.1016/j.jcin.2020.06.019.
- Derived from this study: PubMed 31255562Lim DS, Kar S, Spargias K, Kipperman RM, O'Neill WW, Ng MKC, Fam NP, Walters DL, Webb JG, Smith RL, Rinaldi MJ, Latib A, Cohen GN, Schafer U, Marcoff L, Vandrangi P, Verta P, Feldman TE. Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. JACC Cardiovasc Interv. 2019 Jul 22;12(14):1369-1378. doi: 10.1016/j.jcin.2019.04.034. Epub 2019 Jun 26.
- Individual participant dataSharing planned: Undecided
Related trials for Mitral Valve Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
Edge-to-edge Mitral Valve Repair in ATTR-CM
Mitral Regurgitation, ATTR-Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gideon Cohen, MD principal investigator
Sunnybrook Hospital
Ulrich Schafer, MD principal investigator
BundeswehrZentralkrankenhaus Koblenz
Molly Szerlip, MD principal investigator
The Heart Hospital Baylor
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral Valve Repair in people with Mitral Valve Regurgitation, run by Edwards Lifesciences at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada, Australia, Germany, Greece and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Major Adverse Events (MAE) (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03170349, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.