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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03193801|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2017
Last Update Posted : September 11, 2017
|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)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PARTNER 3 Trial - Mitral Valve in Valve is a Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Mitral Bioprosthetic Valve|
|Estimated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2024|
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 endpoint 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.
- 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.
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
|Contact: Justine Encabo||949-250-3502||Justine_Encabo@edwards.com|
|Contact: Vinny Podichetty, MD||949-250-5794||Vinny_Podichetty@edwards.com|