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PARTNER II Trial: S3iCAP

NCT02687035 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1822

Last updated 2021-04-08

Study results available
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Summary

Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

SAPIEN S3 valve

Transcatheter aortic valve replacement

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Susheel Kodali, MD · University of Columbia

  • Vinod Thourani, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-10-31
Completion
2018-12-31
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02687035 on ClinicalTrials.gov