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EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

NCT03042104 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 901

Last updated 2024-05-13

No results posted yet for this study

Summary

This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.

Conditions

  • Heart Diseases
  • Aortic Stenosis, Severe

Interventions

DEVICE

Edwards SAPIEN 3 / SAPIEN 3 Ultra THV

Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Philippe Généreux, MD · Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-12
Primary Completion
2024-03-31
Completion
2032-03-31
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 NCT03042104 on ClinicalTrials.gov