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NCT03616028 · ClinicalTrials.gov registry record · NA
The CONFORMAL Early Feasibility Study
A NA study of Nonvalvular Atrial Fibrillation, sponsored by Conformal Medical.
- Active
- Registry status
- NA
- Development phase
- 64
- Enrollment target
- 11
- Study locations
NCT03616028: Active NA study of Nonvalvular Atrial Fibrillation, sponsored by Conformal Medical.
NCT03616028 is a NA study of Nonvalvular Atrial Fibrillation that is active but no longer recruiting, run by Conformal Medical. The registered enrollment target is 64 participants, below the 109,279-participant average among 5 other Nonvalvular Atrial Fibrillation trials with a reported enrollment target (100% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03616028, a NA study of Nonvalvular Atrial Fibrillation, is active but no longer recruiting, sponsored by Conformal Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
- 11
- Study locations
Study Summary
An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
Primary Outcome
Major adverse events defined as: All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.
Conditions Studied
Interventions
- DEVICE left atrial appendage closure
Study Locations (11)
New York
- Mount Sinai - New York
- Columbia University Medical Center/NYPH - New York
Tennessee
- Erlanger Health System - Chattanooga
- Vanderbilt University Medical Center - Nashville
Texas
- Texas Cardiac Arrhythmia Institute - Austin
- Baylor Scott & white Research Institute - Plano
Arkansas
- St. Bernards Medical Center - Jonesboro
California
- Pacific Heart Institute - Santa Monica
New Hampshire
- Catholic Medical Center - Manchester
Ohio
- The Christ Hospital - Cincinnati
Pennsylvania
- Lankenau Heart Institute - Wynnewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2019-02-22 |
| Est. Completion | 2028-06 |
| Phase | NA |
What the registry record for NCT03616028 still lists
NCT03616028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 109,279-participant average among 5 other Nonvalvular Atrial Fibrillation trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Nonvalvular Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which left atrial appendage closure is the first listed.
NCT03616028 lists 11 locations in 8 states (New York, Tennessee, Texas).
Frequently Asked Questions
What is clinical trial NCT03616028 about?
NCT03616028 is a clinical study titled "The CONFORMAL Early Feasibility Study". An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
What is the current status of trial NCT03616028?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 64 participants. The study started on 2019-02-22. Estimated completion is 2028-06.
What conditions does trial NCT03616028 study?
This clinical trial studies the following conditions: Nonvalvular Atrial Fibrillation.
What interventions are being tested in trial NCT03616028?
The interventions under investigation include: left atrial appendage closure (DEVICE).
Who is sponsoring clinical trial NCT03616028?
This trial is sponsored by Conformal Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03616028 being conducted?
This trial has 11 study locations across Arkansas, California, New Hampshire, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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