PARTNER 3 Trial - Mitral Valve in Valve

Sponsor

Edwards Lifesciences (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03193801

Collaborator

(none)

Enrollment

Locations

Arm

163

Anticipated Duration (Months)

2.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Insufficiency Mitral Valve Disease Mitral Valve Regurgitation Heart Failure	Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX	N/A

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

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PARTNER 3 Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve

Actual Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Failing mitral transcatheter valve Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.	Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems. Other Names: TMVR

Arm

Intervention/Treatment

Experimental: Failing mitral transcatheter valve

Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.

Device: Edwards SAPIEN 3 transcatheter valve, Model 9600TFX

Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.

Other Names:

TMVR

Outcome Measures

Primary Outcome Measures

Safety and Effectiveness - composite of all-cause mortality and stroke [1 Year]

Secondary Outcome Measures

New York Heart Association (NYHA) Functional Class [30 Days]
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.
Kansas City Cardiomyopathy Questionnaire (KCCQ) [30 days]
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.
Mitral regurgitation [30 days]
Echocardiographic assessment of the degree of mitral valve regurgitation
Pulmonary artery systolic pressure [30 days]
Echocardiographic assessment of pulmonary artery systolic pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322
2	Northwestern University	Chicago	Illinois	United States	60611
3	Northshore University Health System Research Institution	Evanston	Illinois	United States	60201
4	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
5	Mayo Clinic	Rochester	Minnesota	United States	55905
6	Barnes-Jewish Hospital/ Washington University	Saint Louis	Missouri	United States	63110
7	Morristown Medical Center/ Atlantic Health System Hospital	Morristown	New Jersey	United States	07962
8	NYU Lagone Medical Center	New York	New York	United States	10016
9	Columbia University Medical Center/ New York Presbyterian Hospital	New York	New York	United States	10032
10	Providence Heart & Vascular Institution	Portland	Oregon	United States	97225
11	The University of Texas Health Sciences Center at Houston	Houston	Texas	United States	77030
12	The Heart Hospital of Baylor Plano	Plano	Texas	United States	75093
13	The Prince Charles Hospital	Chermside	Queensland	Australia	4032
14	Flinders Medical Centre	Bedford Park	South Australia	Australia	5042
15	Instituto do Coração da Universidade de São Paulo	Cerqueira César	São Paulo	Brazil	05403-900
16	Instituto Dante Pazzanese de Cardiologia	Vila Mariana	São Paulo	Brazil	04012-909
17	St. Paul's Hospital	Vancouver	British Columbia	Canada

Sponsors and Collaborators

Edwards Lifesciences

Investigators

Principal Investigator: Mayra Guerrero, MD, Mayo Clinic
Principal Investigator: Chris S. Malaisrie, MD, Northwestern University Feinberg School of Medicine
Principal Investigator: Alan Zajarias, MD, Washington University School of Medicine