PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate (PII S3i)
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|ClinicalTrials.gov Identifier: NCT03222128|
Recruitment Status : Active, not recruiting
First Posted : July 19, 2017
Results First Posted : August 14, 2018
Last Update Posted : November 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Severe Aortic Stenosis||Device: TAVR||Not Applicable|
This study design consists of PIIS3i cohort.
The PIIS3i cohort is a single arm non-randomized, historical-controlled study. Patients recruited to the treatment arm will receive an Edwards SAPIEN 3 THV with either transfemoral, transapical or transaortic delivery access.
To assure that patients are of "intermediate" risk, an STS score of 4 - 8% has been selected.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1074 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for Intermediate Risk Patients|
|Actual Study Start Date :||February 17, 2014|
|Actual Primary Completion Date :||November 18, 2015|
|Estimated Study Completion Date :||November 2025|
Experimental: PIIS3i - SAPIEN 3
PIIS3i - SAPIEN 3 is Operable Group
Implantation of the SAPIEN 3
- Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate [ Time Frame: 1 year ]
- Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days [ 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): NCT03222128
|Principal Investigator:||Martin B Leon, MD||Columbia University|
|Principal Investigator:||Craig Smith, MD||Columbia University|