PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Symptomatic Severe Aortic Stenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
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 o...
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.
Tracking Information
- NCT #
- NCT03222128
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Martin B Leon, MD Columbia University Principal Investigator: Craig Smith, MD Columbia University
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