PARTNER 3 Trial - Mitral Valve in Valve
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03193801|
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : September 5, 2021
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PARTNER 3 Trial - SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2031|
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 Name: TMVR
- Safety and Effectiveness - composite of all-cause mortality and stroke [ Time Frame: 1 Year ]
- New York Heart Association (NYHA) Functional Class [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 30 days ]Echocardiographic assessment of the degree of mitral valve regurgitation
- Pulmonary artery systolic pressure [ Time Frame: 30 days ]Echocardiographic assessment of pulmonary artery systolic pressure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193801
|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|