PARTNER 3 Trial - Aortic Valve-in-Valve
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|ClinicalTrials.gov Identifier: NCT03003299|
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : April 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis Aortic Stenosis, Severe||Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve|
|Actual Study Start Date :||January 5, 2017|
|Estimated Primary Completion Date :||January 2033|
|Estimated Study Completion Date :||April 2038|
Experimental: TAVR - Failing surgical or transcatheter valve
Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
- Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke [ Time Frame: 1 year ]Number of patients that died and/or had a stroke
- Mean gradient [ Time Frame: 30 days ]Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
- Peak gradient [ Time Frame: 30 days ]Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 30 days ]Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.
- New York Heart Association (NYHA) Classification [ Time Frame: 30 days ]Change from baseline in NYHA. 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.
- Six-Minute Walk Test (6MWT) [ Time Frame: 30 days ]Change from baseline in 6MWT. The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
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): NCT03003299
|Contact: Edwards THV Clinical Affairs||(949) 250-2500||THV_CT.gov@Edwards.com|
|Principal Investigator:||Chris S Malaisrie, MD||Northwestern University Feinberg School of Medicine|
|Principal Investigator:||Alan Zajarias, MD||Washington University School of Medicine|
|Principal Investigator:||Mayra Guerrero, MD||Mayo Clinic|