Mitral Valve InsufficiencyNCT03193801
PARTNER 3 Trial - Mitral Valve in Valve
A study testing Edwards SAPIEN 3 transcatheter valve, Model 9600TFX in people with Mitral Valve Insufficiency and Mitral Valve Disease, run by Edwards Lifesciences at 12 sites in 3 countries.
Trial summary
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation
- What is being tested?
- Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 1 Feb 2018to Aug 2031
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
- Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.
- NYHA Functional Class ≥ II.
- Heart Team agrees the patient is intermediate risk (i.e. STS score of ≥3 and < 8).
- Heart Team agrees valve implantation will likely benefit the patient.
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) / Ethics Committee (EC) of the respective clinical site.
Who cannot join
- Index valve has ≥ mild paravalvular regurgitation where the surgical bioprosthesis is not securely fixed in the native annulus or is not structurally intact as determined by transesophageal echocardiography (TEE).
- Surgical or transcatheter aortic valve placed so that extension into left ventricular outflow tract (LVOT) that may impinge on the mitral implant.
- Known residual mean gradient >10 mmHg at the end of the index procedure for implantation of the original surgical valve.
- Severe right ventricle (RV) dysfunction.
- Anatomical characteristics that would preclude safe access to the apex (transapical).
- Severe regurgitation or stenosis of any other valve.
Show all 30Show fewer
- Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
- Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)
- Anatomical characteristics that would increase risk of LVOT obstruction (e.g., aortomitral angle, LVOT size, etc.).
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before enrollment.
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
- Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
- Leukopenia (white blood count < 3000 cell/mL), anemia (hemoglobin < 9 g/dL), thrombocytopenia (blood platelet count < 50,000 cell/mL), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment.
- Emergency intervention/surgical procedures within one month (30 days) prior to the procedure.
- Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure.
- Hypertrophic cardiomyopathy with obstruction (HOCM).
- Left ventricular ejection fraction (LVEF) < 30%.
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
- Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure.
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication.
- Stroke or transient ischemic attack (TIA) within 90 days of enrollment.
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment.
- Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening.
- Active bacterial endocarditis within 6 months (180 days) of the procedure.
- Patient refuses blood products.
- Estimated life expectancy < 24 months.
- Currently participating in an investigational drug or another device study. Note: Clinical trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- Positive urine or serum pregnancy test in female subjects of childbearing potential.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States9 sites
Emory University
Atlanta, Georgia, 30322
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Northwestern University
Chicago, Illinois, 60611
Northshore University Health System Research Institution
Evanston, Illinois, 60201
NYU Lagone Medical Center
New York, New York, 10016
The Heart Hospital of Baylor Plano
Plano, Texas, 75093
Providence Heart & Vascular Institution
Portland, Oregon, 97225
Mayo Clinic
Rochester, Minnesota, 55905
Barnes-Jewish Hospital/ Washington University
St Louis, Missouri, 63110
Brazil2 sites
Instituto do Coração da Universidade de São Paulo
Cerqueira César, São Paulo, 05403-900
Instituto Dante Pazzanese de Cardiologia
Vila Mariana, São Paulo, 04012-909
About this study
Official title: PARTNER 3 Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
Read the detailed description
A prospective, single-arm, multicenter clinical trial. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined).
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Being tested
- Edwards SAPIEN 3 transcatheter valve, Model 9600TFX
- Keywords
- SAPIEN 3, PARTNER 3, cardiovascular disease, TMVR, failing valve, failing bioprosthetic valve
- Medical subject headings
- Mitral Valve Insufficiency, Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards SAPIEN 3 transcatheter valve, Model 9600TFXDevice
Also called TMVR
Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
| Study group | Role | What they receive |
|---|---|---|
| Failing mitral transcatheter valve | Experimental | Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve. Receives: Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Effectiveness - Composite of All-cause Mortality and Stroke
Non-hierarchical composite endpoint of all-cause mortality and stroke at 1-year post-procedure
Measured: 1 Year
Secondary outcomes (4)
New York Heart Association (NYHA) Functional Class - Change From Baseline
NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
A decrease in NYHA class (negative value) shows patient improvement at 30 days.
Measured: 30 Days
Kansas City Cardiomyopathy Questionnaire (KCCQ) - Change From Baseline
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom, social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
An increase in KCCQ score (positive value) shows patient improvement at 30 days.
Measured: 30 days
Mitral Regurgitation - Change From Baseline
Echocardiographic assessment of the degree of mitral valve regurgitation
None=0, Trace=0.5, Mild or Mild-Moderate=1, Moderate=2, Moderate-Severe=3, and Severe=4.
A decrease in MR (negative value) shows patient improvement at 30 days.
Measured: 30 days
Pulmonary Artery Systolic Pressure - Change From Baseline
Echocardiographic assessment of pulmonary artery systolic pressure
A decrease in pulmonary artery systolic pressure (negative value) shows patient improvement at 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start1 Feb 2018
- Primary completion16 Aug 2022
- Study completionAug 2031 (estimated)
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 (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve InsufficiencyStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayra Guerrero, MD, Principal investigator, Mayo ClinicChris S. Malaisrie, MD, Principal investigator, Northwestern UniversityAlan Zajarias, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193801
- Sponsor's protocol ID
- 2015-08 MVIV
- Status last verified
- Oct 2025
- First submitted
- 19 Jun 2017
- Last updated
- 5 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Malaisrie SC, Guerrero M, Davidson C, Williams M, de Brito FS Jr, Abizaid A, Shah P, Kaneko T, Poon K, Levisay J, Yu X, Pibarot P, Hahn RT, Blanke P, Leon MB, Mack MJ, Zajarias A; PARTNER 3 Mitral Valve-in-Valve Study Investigators. One-Year Outcomes of Transseptal Mitral Valve-in-Valve in Intermediate Surgical Risk Patients. Circ Cardiovasc Interv. 2024 Aug;17(8):e013782. doi: 10.1161/CIRCINTERVENTIONS.123.013782. Epub 2024 Jul 22.
PubMed 39034924
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARTNER 3 Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
- ClinicalTrials.gov ID
- NCT03193801
- Acronym / sponsor ID
- 2015-08 MVIV
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Disease, Mitral Valve Regurgitation, Heart Failure
- Keywords
- SAPIEN 3, PARTNER 3, cardiovascular disease, TMVR, failing valve, failing bioprosthetic valve
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- Aug 2031 (estimated)
- First posted
- 21 Jun 2017 (actual)
- Results
- Posted 24 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
Detailed description
A prospective, single-arm, multicenter clinical trial. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Failing mitral transcatheter valve | Experimental | Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFXPatients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
- Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.
- NYHA Functional Class ≥ II.
- Heart Team agrees the patient is intermediate risk (i.e. STS score of ≥3 and < 8).
- Heart Team agrees valve implantation will likely benefit the patient.
Key exclusion criteria (30 listed)
- Index valve has ≥ mild paravalvular regurgitation where the surgical bioprosthesis is not securely fixed in the native annulus or is not structurally intact as determined by transesophageal echocardiography (TEE).
- Surgical or transcatheter aortic valve placed so that extension into left ventricular outflow tract (LVOT) that may impinge on the mitral implant.
- Known residual mean gradient >10 mmHg at the end of the index procedure for implantation of the original surgical valve.
- Severe right ventricle (RV) dysfunction.
- Anatomical characteristics that would preclude safe access to the apex (transapical).
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 SAPIEN 3 transcatheter valve, Model 9600TFXAlso: TMVREdwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems. | Device | Failing mitral transcatheter valve |
Primary outcome
Safety and Effectiveness - Composite of All-cause Mortality and Stroke
Time frame: 1 Year
Non-hierarchical composite endpoint of all-cause mortality and stroke at 1-year post-procedure
4 secondary outcomes
New York Heart Association (NYHA) Functional Class - Change From Baseline
Time frame: 30 Days
Kansas City Cardiomyopathy Questionnaire (KCCQ) - Change From Baseline
Time frame: 30 days
Mitral Regurgitation - Change From Baseline
Time frame: 30 days
Pulmonary Artery Systolic Pressure - Change From Baseline
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39034924Malaisrie SC, Guerrero M, Davidson C, Williams M, de Brito FS Jr, Abizaid A, Shah P, Kaneko T, Poon K, Levisay J, Yu X, Pibarot P, Hahn RT, Blanke P, Leon MB, Mack MJ, Zajarias A; PARTNER 3 Mitral Valve-in-Valve Study Investigators. One-Year Outcomes of Transseptal Mitral Valve-in-Valve in Intermediate Surgical Risk Patients. Circ Cardiovasc Interv. 2024 Aug;17(8):e013782. doi: 10.1161/CIRCINTERVENTIONS.123.013782. Epub 2024 Jul 22.
- Individual participant dataSharing planned: No
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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
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
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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.
Mayra Guerrero, MD principal investigator
Mayo Clinic
Chris S. Malaisrie, MD principal investigator
Northwestern University
Alan Zajarias, MD principal investigator
Washington University School of Medicine
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards SAPIEN 3 transcatheter valve, Model 9600TFX in people with Mitral Valve Insufficiency and Mitral Valve Disease, run by Edwards Lifesciences at 12 sites in 3 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 6 inclusion and 30 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 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Brazil, Australia. 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 24 Oct 2023). 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?
Safety and Effectiveness - Composite of All-cause Mortality and Stroke (time frame: 1 Year). 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 NCT03193801, which also lists 1 linked publication.
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 Nov 2025.