Degenerative Mitral Valve DiseaseCLASP IID/IIFNCT03706833
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
A study testing Edwards PASCAL System and Abbott Mitraclip System in people with Degenerative Mitral Valve Disease and Mitral Regurgitation, run by Edwards Lifesciences at 81 sites in 4 countries.
Trial summary
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency
- What is being tested?
- Edwards PASCAL System and Abbott Mitraclip System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,247 participants
- Where
- 81 sitesin 4 countries
- Study dates
- 30 Nov 2018to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Eighteen (18) years of age or older
- Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
- Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
- Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
- Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
- Mitral regurgitation (3+ to 4+) by echo
Show all 9Show fewer
- Suitable valve and regurgitant jet morphology
- Elevated corrected BNP > 400 pg/ml or corrected NT-pro BNP of > 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
- LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)
Who cannot join
- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
- Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
- Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
- Clinically significant, untreated coronary artery disease
- Recent stroke
- Other severe valve disorders requiring intervention
Show all 18Show fewer
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
- Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
- Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
- Active rheumatic heart disease or rheumatic etiology for MR
- Severe aortic stenosis or regurgitation
- Known history of untreated, severe carotid stenosis
- Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Severe COPD
- Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
- Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
Trial locations and contacts
81 sites in 4 countries.
81 sites in 4 countries
United States63 sites
Albany Medical College
Albany, New York, 12208
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Healthcare
Atlanta, Georgia, 30309
Emory University Hospital and Emory University Hospital Midtown
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Woman's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
State University of New York at Buffalo
Buffalo, New York, 14203
St. Vincent Heart Center
Carmel, Indiana, 46290
University of Virginia
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
The Christ Hospital
Cincinnati, Ohio, 45219-2906
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48202
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, 32605
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
St.Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
CVA Heart Institute Kingsport
Kingsport, Tennessee, 37660
Scripps Memorial Hospital La Jolla
La Jolla, California, 92071
Cedars Sinai Medical Center
Los Angeles, California, 90048
Medical Center of the Rockies
Loveland, Colorado, 80538
Baptist Memorial Hospital Memphis
Memphis, Tennessee, 38138
Mount Sinai
Miami Beach, Florida, 33140
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Morristown Medical Center
Morristown, New Jersey, 07960
NCH Rooney Heart Institute
Naples, Florida, 34102
Centennial Medical Center
Nashville, Tennessee, 37203
Saint Thomas Heart at Saint Thomas West
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Rutgers-RWJMS
New Brunswick, New Jersey, 08901
NYU Langone Health
New York, New York, 10016
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Lenox Hill Hospital and North Shore University
New York, New York, 10075
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Oklahoma Cardiovascular
Oklahoma City, Oklahoma, 73120
UC Irvine
Orange, California, 92868
AdventHealth Orlando
Orlando, Florida, 32803
Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Banner University Medical Center
Phoenix, Arizona, 85006
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
Rochester General Hospital
Rochester, New York, 14621
Sutter Medical Center-Sacramento
Sacramento, California, 95618
Intermountain Medical Center
Salt Lake City, Utah, 84107
Kaiser Permanente San Francisco
San Francisco, California, 94118
University of California, San Francisco
San Francisco, California, 94143
Swedish Medical Center
Seattle, Washington, 98122
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360
TMC Healthcare
Tucson, Arizona, 85712
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg
Wormleysburg, Pennsylvania, 17043
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
WellSpan York Hospital
York, Pennsylvania, 17405
Germany12 sites
Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, 32545
Herzzentrum Universitätsklinikum Koln
Cologne, 50937
Herrzentrum Dresden GmbH Universitätklinik an der Technischen Universität Dresden
Dresden, 01307
Universitätsklinikum Essen (AöR) Klinik für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum
Essen, 45174
Universitätsklinikum Gießen Medizinische Klinik I, Innere Medizin/ Kardiologie
Giessen, 35392
Universitäres Herzzentrum Hamburg GmbH (UHZ) Klinik und Poliklinik für Allgemeneine und Interventionelle Kardiologie
Hamburg, 20246
Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, Pneumologie
Heidelberg, 69120
Herzzentrum Leipzig Universitätsklinik für Kardiologie
Leipzig, 04289
Zentrum für Kardiologie - Kardiologie I Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, 55131
Medizinische Klinik I LMU München Campus Grosshadern
München, 81377
Helios Klinikum Siegburg
Siegburg, 53721
ULM University Zentrum für Innere Medizin Klinik für Innere Medizin II
Ulm, 89081
Canada5 sites
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULaval
Québec, G1V 4G5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St. Pauls Hospital
Vancouver, British Columbia, V6E 1M7
About this study
Official title: Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Read the detailed description
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
- Conditions
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
- Being tested
- Edwards PASCAL System, Abbott Mitraclip System
- 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.
Edwards PASCAL SystemDevice
Also called Transcatheter Mitral Valve repair (TMVr)
Transcatheter mitral valve repair with the Edwards PASCAL System
Abbott Mitraclip SystemDevice
Also called Transcatheter Mitral Valve repair (TMVr)
Transcatheter mitral valve repair with the Abbott Mitraclip System
| Study group | Role | What they receive |
|---|---|---|
| Edwards PASCAL System - CLASP IID | Experimental | Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation Receives: Device: Edwards PASCAL System |
| Abbott Mitraclip System - CLASP IID | Active comparator | Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation Receives: Device: Abbott Mitraclip System |
| Edwards PASCAL System - CLASP IIF | Experimental | Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation Receives: Device: Edwards PASCAL System |
| Abbott Mitraclip System - CLASP IIF | Active comparator | Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation Receives: Device: Abbott Mitraclip System |
| Edwards PASCAL System - Single-Arm Registry | Experimental | Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system. Receives: Device: Edwards PASCAL System |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).
Measured: 30 days.
PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.
Measured: 6 months
PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.
Measured: From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
Secondary outcomes (5)
Rates of various adverse events
Rates of various adverse events at 6 and 12 months
Measured: 6 months; 12 months
Functional Improvement (increase in 6 minute walk test in meters)
Increase in 6 minute walk test in meters
Measured: 30 days , 6 months, 1 year
Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years
Number of points of improvement on a scale of 0-100 in Kansas City Cardiomyopathy Questionnaire, with higher scores associated with higher Quality of Life
Measured: 30 days , 6 months, 1 year, 2 year
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years
Number of points of improvement on a scale of 0-100 in Short Form Health Survey (SF-36) questionnaire, with higher totals associated with higher Quality of Life
Measured: 30 days, 6 months, 1 year, 2 year
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through
Number of points of improvement on a scale of 1-100 in Short Form Health Survey (EQ-5D-5L) questionnaire, with higher totals associated with higher Quality of Life
Measured: 30 days, 6 months, 1 year, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start30 Nov 2018
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Degenerative Mitral Valve DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,247 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Lim, MD, Principal investigator, University of VirginiaRobert Smith, MD, Principal investigator, The Heart Hospital Baylor PlanoLinda Gillam, MD, Principal investigator, Morristown Medical CenterVinod Thourani, MD, Principal investigator, Piedmont HealthcarePaul Grayburn, MD, Principal investigator, The Heart Hospital Baylor PlanoBrian K Whisenant, MD, Principal investigator, Intermountain Health Care, Inc.Jörg Hausleiter, MD, Principal investigator, LMU München, Campus GorsshadernRalph Stephan von Bardeleben, MD, Principal investigator, / Universitätsmedizin Mainz- Zentrum für Kardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706833
- Sponsor's protocol ID
- 2018-07
- Acronym
- CLASP IID/IIF
- Status last verified
- Jul 2026
- First submitted
- 10 Oct 2018
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Narang A, Hausleiter J, Lim DS, Smith RL, Zahr F, Chadderdon S, Puthumana J, Makkar R, Makar MM, Stephan von Bardeleben R, Ruf TF, Gossler T, Kipperman RM, Rassi AN, Ku IA, Nabauer M, Szerlip M, Wang Z, Goldman S, Hawthorne KM, Koulogiannis K, Marcoff L, Gillam LD, Davidson CJ; CLASP IID Pivotal Trial Investigators. Impact of Residual Mitral Regurgitation and Gradient After M-TEER: 1-Year Outcomes From the CLASP IID Trial. JACC Cardiovasc Imaging. 2026 Jul;19(7):795-806. doi: 10.1016/j.jcmg.2026.04.005. Epub 2026 Jun 3.
PubMed 42233921Marcoff L, Koulogiannis K, Aldaia L, Mediratta A, Chadderdon SM, Makar MM, Ruf TF, Gossler T, Zaroff JG, Leung GK, Ku IA, Nabauer M, Grayburn PA, Wang Z, Hawthorne KM, Fowler DE, Dal-Bianco JP, Vannan MA, Bevilacqua C, Meineri M, Ender J, Forner AF, Puthumana JJ, Mansoor AH, Lloyd DJ, Voskanian SJ, Ghobrial A, Hahn RT, Mahmood F, Haeffele C, Ong G, Schneider LM, Wang DD, Sekaran NK, Koss E, Mehla P, Harb S, Miyasaka R, Ivannikova M, Stewart-Dehner T, Mitchel L, Raissi SR, Kalbacher D, Biswas S, Ho EC, Goldberg Y, Smith RL, Hausleiter J, Lim DS, Gillam LD; CLASP IID Pivotal Trial Investigators. Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Imaging. 2024 May;17(5):471-485. doi: 10.1016/j.jcmg.2023.09.015. Epub 2023 Dec 13.
PubMed 38099912Hausleiter J, Lim DS, Gillam LD, Zahr F, Chadderdon S, Rassi AN, Makkar R, Goldman S, Rudolph V, Hermiller J, Kipperman RM, Dhoble A, Smalling R, Latib A, Kodali SK, Lazkani M, Choo J, Lurz P, O'Neill WW, Laham R, Rodes-Cabau J, Kar S, Schofer N, Whisenant B, Inglessis-Azuaje I, Baldus S, Kapadia S, Koulogiannis K, Marcoff L, Smith RL; PASCAL IID Registry Investigators. Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation. J Am Coll Cardiol. 2023 Feb 7;81(5):431-442. doi: 10.1016/j.jacc.2022.11.034.
PubMed 36725171Lim DS, Smith RL, Gillam LD, Zahr F, Chadderdon S, Makkar R, von Bardeleben RS, Kipperman RM, Rassi AN, Szerlip M, Goldman S, Inglessis-Azuaje I, Yadav P, Lurz P, Davidson CJ, Mumtaz M, Gada H, Kar S, Kodali SK, Laham R, Hiesinger W, Fam NP, Kessler M, O'Neill WW, Whisenant B, Kliger C, Kapadia S, Rudolph V, Choo J, Hermiller J, Morse MA, Schofer N, Gafoor S, Latib A, Koulogiannis K, Marcoff L, Hausleiter J; CLASP IID Pivotal Trial Investigators. Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Interv. 2022 Dec 26;15(24):2523-2536. doi: 10.1016/j.jcin.2022.09.005. Epub 2022 Sep 17.
PubMed 36121247
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT03706833
- Acronym / sponsor ID
- CLASP IID/IIF / 2018-07
- Conditions
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,247 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Detailed description
A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Edwards PASCAL System - CLASP IID | Experimental | Device: Edwards PASCAL SystemTranscatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation |
| Abbott Mitraclip System - CLASP IID | Active comparator | Device: Abbott Mitraclip SystemTranscatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation |
| Edwards PASCAL System - CLASP IIF | Experimental | Device: Edwards PASCAL SystemTranscatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation |
| Abbott Mitraclip System - CLASP IIF | Active comparator | Device: Abbott Mitraclip SystemTranscatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation |
| Edwards PASCAL System - Single-Arm Registry | Experimental | Device: Edwards PASCAL SystemTranscatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eighteen (18) years of age or older
- Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
- Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
- Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
- Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
Key exclusion criteria (18 listed)
- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
- Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
- Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
- Clinically significant, untreated coronary artery disease
- Recent stroke
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 |
|---|---|---|
| Edwards PASCAL SystemAlso: Transcatheter Mitral Valve repair (TMVr)Transcatheter mitral valve repair with the Edwards PASCAL System | Device | Edwards PASCAL System - CLASP IID, Edwards PASCAL System - CLASP IIF, Edwards PASCAL System - Single-Arm Registry |
| Abbott Mitraclip SystemAlso: Transcatheter Mitral Valve repair (TMVr)Transcatheter mitral valve repair with the Abbott Mitraclip System | Device | Abbott Mitraclip System - CLASP IID, Abbott Mitraclip System - CLASP IIF |
Primary outcome
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).
Time frame: 30 days.
PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.
Time frame: 6 months
PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.
Time frame: From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
5 secondary outcomes
Rates of various adverse events
Time frame: 6 months; 12 months
Functional Improvement (increase in 6 minute walk test in meters)
Time frame: 30 days , 6 months, 1 year
Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years
Time frame: 30 days , 6 months, 1 year, 2 year
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years
Time frame: 30 days, 6 months, 1 year, 2 year
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through
Time frame: 30 days, 6 months, 1 year, 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 42233921Narang A, Hausleiter J, Lim DS, Smith RL, Zahr F, Chadderdon S, Puthumana J, Makkar R, Makar MM, Stephan von Bardeleben R, Ruf TF, Gossler T, Kipperman RM, Rassi AN, Ku IA, Nabauer M, Szerlip M, Wang Z, Goldman S, Hawthorne KM, Koulogiannis K, Marcoff L, Gillam LD, Davidson CJ; CLASP IID Pivotal Trial Investigators. Impact of Residual Mitral Regurgitation and Gradient After M-TEER: 1-Year Outcomes From the CLASP IID Trial. JACC Cardiovasc Imaging. 2026 Jul;19(7):795-806. doi: 10.1016/j.jcmg.2026.04.005. Epub 2026 Jun 3.
- Derived from this study: PubMed 38099912Marcoff L, Koulogiannis K, Aldaia L, Mediratta A, Chadderdon SM, Makar MM, Ruf TF, Gossler T, Zaroff JG, Leung GK, Ku IA, Nabauer M, Grayburn PA, Wang Z, Hawthorne KM, Fowler DE, Dal-Bianco JP, Vannan MA, Bevilacqua C, Meineri M, Ender J, Forner AF, Puthumana JJ, Mansoor AH, Lloyd DJ, Voskanian SJ, Ghobrial A, Hahn RT, Mahmood F, Haeffele C, Ong G, Schneider LM, Wang DD, Sekaran NK, Koss E, Mehla P, Harb S, Miyasaka R, Ivannikova M, Stewart-Dehner T, Mitchel L, Raissi SR, Kalbacher D, Biswas S, Ho EC, Goldberg Y, Smith RL, Hausleiter J, Lim DS, Gillam LD; CLASP IID Pivotal Trial Investigators. Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Imaging. 2024 May;17(5):471-485. doi: 10.1016/j.jcmg.2023.09.015. Epub 2023 Dec 13.
- Derived from this study: PubMed 36725171Hausleiter J, Lim DS, Gillam LD, Zahr F, Chadderdon S, Rassi AN, Makkar R, Goldman S, Rudolph V, Hermiller J, Kipperman RM, Dhoble A, Smalling R, Latib A, Kodali SK, Lazkani M, Choo J, Lurz P, O'Neill WW, Laham R, Rodes-Cabau J, Kar S, Schofer N, Whisenant B, Inglessis-Azuaje I, Baldus S, Kapadia S, Koulogiannis K, Marcoff L, Smith RL; PASCAL IID Registry Investigators. Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation. J Am Coll Cardiol. 2023 Feb 7;81(5):431-442. doi: 10.1016/j.jacc.2022.11.034.
- Derived from this study: PubMed 36121247Lim DS, Smith RL, Gillam LD, Zahr F, Chadderdon S, Makkar R, von Bardeleben RS, Kipperman RM, Rassi AN, Szerlip M, Goldman S, Inglessis-Azuaje I, Yadav P, Lurz P, Davidson CJ, Mumtaz M, Gada H, Kar S, Kodali SK, Laham R, Hiesinger W, Fam NP, Kessler M, O'Neill WW, Whisenant B, Kliger C, Kapadia S, Rudolph V, Choo J, Hermiller J, Morse MA, Schofer N, Gafoor S, Latib A, Koulogiannis K, Marcoff L, Hausleiter J; CLASP IID Pivotal Trial Investigators. Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Interv. 2022 Dec 26;15(24):2523-2536. doi: 10.1016/j.jcin.2022.09.005. Epub 2022 Sep 17.
- Individual participant dataSharing planned: No
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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.
Scott Lim, MD principal investigator
University of Virginia
Robert Smith, MD principal investigator
The Heart Hospital Baylor Plano
Linda Gillam, MD principal investigator
Morristown Medical Center
81 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards PASCAL System and Abbott Mitraclip System in people with Degenerative Mitral Valve Disease and Mitral Regurgitation, run by Edwards Lifesciences at 81 sites in 4 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 9 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, Germany, Canada, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). (time frame: 30 days.). The study lists 3 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 NCT03706833, which also lists 4 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 8 Jul 2026.