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PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

NCT04889872 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2250

Last updated 2025-12-17

No results posted yet for this study

Summary

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Conditions

  • Aortic Stenosis, Calcific
  • Aortic Valve Stenosis

Interventions

DEVICE

SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Philippe Généreux, MD · Morristown Medical Center, Morristown, NJ, USA

  • Jeroen J Bax, MD, PhD · Leiden University Medical Center, Leiden, The Netherlands

  • Raj Makkar, MD · Cedars-Sinai Medical Center, Los Angeles, CA, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2029-06-30
Completion
2037-06-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Japan
  • Netherlands
  • Switzerland

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 NCT04889872 on ClinicalTrials.gov