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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: Recruiting NA study of Aortic Valve Stenosis and Aortic Stenosis, Calcific, sponsored by Edwards Lifesciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Non-hierarchical composite of death, and heart failure hospitalization or event
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 2,250 participants |
| Start Date | 2021-10-12 |
| Est. Completion | 2037-06 |
| Phase | NA |
What NCT04889872 shows while recruiting
NCT04889872 is an interventional study that assigns participants to a tested intervention. Its 2,250 participants enrollment target places it among the larger protocols in the corpus, above the 968-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (132% higher).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
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Where NCT04889872's enrollment target sits among peer trials
2,250 2nd of 30 the highest of 30 other Aortic Valve Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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