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Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis

NCT02628899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2024-05-16

No results posted yet for this study

Summary

To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Transfemoral TAVR

DEVICE

SAVR

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2023-01-31
Completion
2023-01-31
FDA Device
Yes

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 NCT02628899 on ClinicalTrials.gov