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NCT04889872 · ClinicalTrials.gov registry record · NA

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

A NA study of Aortic Valve Stenosis and Aortic Stenosis, Calcific, sponsored by Edwards Lifesciences.

Recruiting
Registry status
NA
Development phase
2,250
Enrollment target
20
Study locations

NCT04889872 is a NA study of Aortic Valve Stenosis and Aortic Stenosis, Calcific that is actively recruiting participants, run by Edwards Lifesciences. The registered enrollment target is 2,250 participants, above the 968-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (132% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT04889872, a NA study of Aortic Valve Stenosis and Aortic Stenosis, Calcific, is actively recruiting participants, sponsored by Edwards Lifesciences.

RECRUITING
Registry status
NA
Development phase
2,250 participants
Enrollment target
20
Study locations

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 Studied

Aortic Valve Stenosis Aortic Stenosis, Calcific

Interventions

  • DEVICE SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA

Study Locations (20)

California

  • Cedars-Sinai Medical Center - Los Angeles
  • Huntington Hospital - Pasadena
  • Eisenhower Desert Cardiology Center - Rancho Mirage
  • Bay Area Structural Heart at Sutter Health - San Francisco
  • Kaiser San Francisco Medical Center - San Francisco
  • University of California San Francisco - San Francisco
  • Santa Barbara Cottage Hospital - Santa Barbara
  • Stanford Univeristy - Stanford

Florida

  • The Cardiac & Vascular Institute Research Foundation - Gainesville
  • Baptist Health Research Center - Jacksonville
  • Sarasota Memorial Health Care System - Sarasota

Georgia

  • Emory University Atlanta - Atlanta
  • Piedmont Heart Institute - Atlanta

Illinois

  • Rush University Medical Center - Chicago
  • Alexian Brothers Hospital - Lisle

Alabama

  • Heart Center LLC, Huntsville - Huntsville

Arizona

  • Tucson Medical Center - Tucson

Colorado

  • UC Health Medical Center of the Rockies - Loveland

Connecticut

  • Yale Universtiy - New Haven

Trial Details

FieldValue
Enrollment Target 2,250 participants
Start Date 2021-10-12
Est. Completion 2037-06
Phase NA

Sponsor

Edwards Lifesciences

57 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04889872

The ClinicalTrials.gov registry entry for NCT04889872 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 2,250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 968-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (132% higher). The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 1 intervention - of which SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA is the first listed.

NCT04889872 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT04889872 about?

NCT04889872 is a clinical study titled "PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR". 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 ...

What is the current status of trial NCT04889872?

This trial is currently recruiting. It is a NA study. The enrollment target is 2,250 participants. The study started on 2021-10-12. Estimated completion is 2037-06.

What conditions does trial NCT04889872 study?

This clinical trial studies the following conditions: Aortic Valve Stenosis, Aortic Stenosis, Calcific.

What interventions are being tested in trial NCT04889872?

The interventions under investigation include: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA (DEVICE).

Who is sponsoring clinical trial NCT04889872?

This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04889872 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.