Clinical trial NCT03193801: PARTNER 3 Trial - Mitral Valve in Valve
Official title: PARTNER 3 Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2017-06-21
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Eligibility criteria: Inclusion Criteria:

1. Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
2. Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.
3. NYHA Functional Class ≥ II.
4. Heart Team agrees the patient is intermediate risk (i.e. STS score of ≥3 and \< 8).
5. Heart Team agrees valve implantation will likely benefit the patient.
6. 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:

1. 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).
2. Surgical or transcatheter aortic valve placed so that extension into left ventricular outflow tract (LVOT) that may impinge on the mitral implant.
3. Known residual mean gradient \>10 mmHg at the end of the index procedure for implantation of the original surgical valve.
4. Severe right ventricle (RV) dysfunction.
5. Anatomical characteristics that would preclude safe access to the apex (transapical).
6. Severe regurgitation or stenosis of any other valve.
7. Severe lung disease (FEV1 \< 50% predicted) or currently on home oxygen
8. Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)
9. Anatomical characteristics that would increase risk of LVOT obstruction (e.g., aortomitral angle, LVOT size, etc.).
10. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before enrollment.
11. 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.
12. Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
13. 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.
14. Untreated clinically significant coronary artery disease requiring revascularization.
15. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment.
16. Emergency intervention/surgical procedures within one month (30 days) prior to the procedure.
17. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure.
18. Hypertrophic cardiomyopathy with obstruction (HOCM).
19. Left ventricular ejection fraction (LVEF) \< 30%.
20. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation.
21. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure.
22. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication.
23. Stroke or transient ischemic attack (TIA) within 90 days of enrollment.
24. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment.
25. Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening.
26. Active bacterial endocarditis within 6 months (180 days) of the procedure.
27. Patient refuses blood products.
28. Estimated life expectancy \< 24 months.
29. 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.
30. Positive urine or serum pregnancy test in female subjects of childbearing potential.

Primary outcomes:
measure: Safety and Effectiveness - Composite of All-cause Mortality and Stroke
timeFrame: 1 Year
Secondary outcomes:
measure: New York Heart Association (NYHA) Functional Class - Change From Baseline
timeFrame: 30 Days
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) - Change From Baseline
timeFrame: 30 days
measure: Mitral Regurgitation - Change From Baseline
timeFrame: 30 days
measure: Pulmonary Artery Systolic Pressure - Change From Baseline
timeFrame: 30 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: Northshore University Health System Research Institution
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital/ Washington University
state: Missouri
city: New York
country: United States
facility: NYU Lagone Medical Center
state: New York
city: Portland
country: United States
facility: Providence Heart & Vascular Institution
state: Oregon
city: Plano
country: United States
facility: The Heart Hospital of Baylor Plano
state: Texas
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Cerqueira César
country: Brazil
facility: Instituto do Coração da Universidade de São Paulo
state: São Paulo
city: Vila Mariana
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
state: São Paulo
Study officials:
affiliation: Mayo Clinic
name: Mayra Guerrero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University Feinberg School of Medicine
name: Chris S. Malaisrie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Alan Zajarias, MD
role: PRINCIPAL_INVESTIGATOR
References: