Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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

NCT04889872 · View on ClinicalTrials.gov ↗

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.

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

34 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04889872 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04889872?

The interventions under investigation include: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04889872?

This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial