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NCT05565599 · ClinicalTrials.gov registry record · NA
An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
A NA study of Nonvalvular Atrial Fibrillation, sponsored by Biosense Webster.
- Active
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 7
- Study locations
NCT05565599: Active NA study of Nonvalvular Atrial Fibrillation, sponsored by Biosense Webster.
NCT05565599 is a NA study of Nonvalvular Atrial Fibrillation that is active but no longer recruiting, run by Biosense Webster. The registered enrollment target is 45 participants, below the 109,283-participant average among 5 other Nonvalvular Atrial Fibrillation trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05565599, a NA study of Nonvalvular Atrial Fibrillation, is active but no longer recruiting, sponsored by Biosense Webster.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is an early feasibility study is to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure System to treat patients with non-valvular atrial fibrillation that cannot take, or a have a reason to seek an alternative, to anticoagulant medications.
Primary Outcome
Composite rate of all-cause mortality, stroke, systemic embolism, life threatening or major bleeding (BARC Type 3 or 5), pericardial effusion requiring drainage, device embolization, and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.
Conditions Studied
Interventions
- DEVICE Left Atrial Appendage Closure
Study Locations (7)
California
- Scripps Health - La Jolla
- UC Davis Medical Center - Sacramento
- Los Robles Hospital & Medical Center - Thousand Oaks
New York
- The Mount Sinai Hospital - New York
- Columbia U. Medical Center / NY Presbyterian Hospital - New York
Arizona
- Tucson Medical Center - Tucson
Arkansas
- St. Bernards Medical Center - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2022-10-21 |
| Est. Completion | 2029-09-01 |
| Phase | NA |
What the registry record for NCT05565599 still lists
NCT05565599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 109,283-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.
NCT05565599 lists 7 locations in 4 states (California, New York, Arizona).
Frequently Asked Questions
What is clinical trial NCT05565599 about?
NCT05565599 is a clinical study titled "An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation". This is an early feasibility study is to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure System to treat patients with non-valvular atrial fibrillation that cannot take, or a have a reason to seek an alternative, to anticoagulant medications.
What is the current status of trial NCT05565599?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 45 participants. The study started on 2022-10-21. Estimated completion is 2029-09-01.
What conditions does trial NCT05565599 study?
This clinical trial studies the following conditions: Nonvalvular Atrial Fibrillation.
What interventions are being tested in trial NCT05565599?
The interventions under investigation include: Left Atrial Appendage Closure (DEVICE).
Who is sponsoring clinical trial NCT05565599?
This trial is sponsored by Biosense Webster, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05565599 being conducted?
This trial has 7 study locations across Arizona, Arkansas, California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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