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Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement

NCT01240902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1453

Last updated 2022-10-25

Study results available
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Summary

The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.

Conditions

  • Severe Aortic Stenosis

Interventions

DEVICE

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

DEVICE

Surgical Aortic Valve Replacement (SAVR)

Surgical Aortic Valve Replacement (SAVR)

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • David H Adams, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-10
Primary Completion
2014-08-31
Completion
2019-05-15

Countries

  • United States

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 NCT01240902 on ClinicalTrials.gov