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NCT03517436 · ClinicalTrials.gov registry record · NA
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
A NA study of Aortic Valve Stenosis, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 101
- Enrollment target
- 20
- Study locations
NCT03517436: Active NA study of Aortic Valve Stenosis, sponsored by Edwards Lifesciences.
NCT03517436 is a NA study of Aortic Valve Stenosis that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 101 participants, below the 1,040-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03517436, a NA study of Aortic Valve Stenosis, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 101 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
Primary Outcome
Number of participants that died
Conditions Studied
Interventions
- DEVICE TAVR with CENTERA THV
Study Locations (20)
California
- Cedars-Sinai Medical Center - Los Angeles
- Stanford University Medical Center - Stanford
Kansas
- University of Kansas Health System - Kansas City
- Cardiovascular Research Institute of Kansas - Wichita
Pennsylvania
- University of Pennsylvania - Philadelphia
- Allegheny - Singer Research Institute - Pittsburgh
Texas
- Baylor Heart and Vascular Hospital - Dallas
- The University of Texas Health Science Center at Houston - Houston
Colorado
- UC Health Northern Colorado (Medical Center of the Rockies) - Loveland
District of Columbia
- Washington Hospital Center - Washington D.C.
Florida
- Sarasota Memorial Hospital - Sarasota
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2030-07 |
| Phase | NA |
What the registry record for NCT03517436 still lists
NCT03517436 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 1,040-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 1 intervention - of which TAVR with CENTERA THV is the first listed.
NCT03517436 names 20 study sites across 16 states, led by California, Kansas, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03517436 about?
NCT03517436 is a clinical study titled "ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis". This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
What is the current status of trial NCT03517436?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 101 participants. The study started on 2018-09-18. Estimated completion is 2030-07.
What conditions does trial NCT03517436 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis.
What interventions are being tested in trial NCT03517436?
The interventions under investigation include: TAVR with CENTERA THV (DEVICE).
Who is sponsoring clinical trial NCT03517436?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03517436 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03517436's enrollment target sits among peer trials
101 19th of 30 higher than 12 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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