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NCT03042104 · ClinicalTrials.gov registry record · NA
EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
A NA study of Heart Diseases and Aortic Stenosis, Severe, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 901
- Enrollment target
- 20
- Study locations
NCT03042104: Active NA study of Heart Diseases and Aortic Stenosis, Severe, sponsored by Edwards Lifesciences.
NCT03042104 is a NA study of Heart Diseases and Aortic Stenosis, Severe that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 901 participants, below the 5,522-participant average among 85 other Heart Diseases trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03042104, a NA study of Heart Diseases and Aortic Stenosis, Severe, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 901 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The number of patients that have any of these conditions
Conditions Studied
Interventions
- DEVICE Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Study Locations (20)
California
- Mills Peninsula Health Services - Burlingame
- Cedars-Sinai Medical Center - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
- Huntington Hospital - Pasadena
- UC Davis Medical Center - Sacramento
- Kaiser San Francisco Medical Center - San Francisco
- Stanford Hospital and Clinics Palo Alto - Stanford
Illinois
- Northwestern University - Chicago
- Rush University Medical Center Chicago - Chicago
- NorthShore University HealthSystem Research Institution - Evanston
- Alexian Brothers Hospital Network - Lisle
- Prairie Education and Research Cooperative - Springfield
Florida
- The Cardiac & Vascular Institute Research Foundation - Gainesville
- University of Florida - Gainesville
Georgia
- Piedmont Heart Institute - Atlanta
- Emory University - Atlanta
Arizona
- Banner University Medical Center - Phoenix
Colorado
- UC Health Northern Colorado (Medical Center of the Rockies) - Loveland
Connecticut
- Yale University - New Haven
District of Columbia
- Washington Hospital Center DC - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 901 participants |
| Start Date | 2017-07-12 |
| Est. Completion | 2032-03 |
| Phase | NA |
What the registry record for NCT03042104 still lists
NCT03042104 is an interventional study that assigns participants to a tested intervention. The registered 901 participants enrollment target is mid-sized for trials with a published cap, below the 5,522-participant average among 85 other Heart Diseases trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Heart Diseases appearing as the primary indexed condition, and to 1 intervention - of which Edwards SAPIEN 3 / SAPIEN 3 Ultra THV is the first listed.
NCT03042104 names 20 study sites across 8 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT03042104 about?
NCT03042104 is a clinical study titled "EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis". 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.
What is the current status of trial NCT03042104?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 901 participants. The study started on 2017-07-12. Estimated completion is 2032-03.
What conditions does trial NCT03042104 study?
This clinical trial studies the following conditions: Heart Diseases, Aortic Stenosis, Severe.
What interventions are being tested in trial NCT03042104?
The interventions under investigation include: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV (DEVICE).
Who is sponsoring clinical trial NCT03042104?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03042104 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03042104's enrollment target sits among peer trials
901 26th of 85 higher than 60 of 85 other Heart Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Diseases 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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