The PARTNER 3 - Trial - The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3)
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|ClinicalTrials.gov Identifier: NCT02675114|
Recruitment Status : Active, not recruiting
First Posted : February 5, 2016
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis||Procedure: Surgical aortic valve replacement (SAVR) Device: Transcatheter Aortic Valve Replacement (TAVR)||Not Applicable|
Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.
A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/QOL. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2029|
|Active Comparator: Surgical aortic valve replacement (SAVR)||
Procedure: Surgical aortic valve replacement (SAVR)
SAVR with a commercially available bioprosthetic valve.
Other Name: SAVR
|Experimental: Edwards SAPIEN 3 THV||
Device: Transcatheter Aortic Valve Replacement (TAVR)
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
- All-cause mortality, all stroke, and re-hospitalization [ Time Frame: 1 year post procedure ]
- Length of index hospitalization (Device and Control group) [ Time Frame: Number of days from index procedure to discharge (expected average of 7 days) ]
- Death or Stroke [ Time Frame: 30 Days ]
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): NCT02675114
|Principal Investigator:||Martin B Leon, MD, FACC||Columbia University Medical Center/ New York Presbyterian Hospital, NY|
|Principal Investigator:||Michael J Mack, MD, FACC||The Heart Hospital Baylor Plano, TX|