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NCT01997905 · ClinicalTrials.gov registry record · Phase 1
Stroke Feasibility Study
A Phase 1 study of Atrial Fibrillation and Afib, sponsored by AtriCure.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 7
- Study locations
NCT01997905: Completed Phase 1 study of Atrial Fibrillation and Afib, sponsored by AtriCure.
NCT01997905 is a Phase 1 study of Atrial Fibrillation and Afib that has completed, run by AtriCure. The registered enrollment target is 13 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01997905, a Phase 1 study of Atrial Fibrillation and Afib, has completed, sponsored by AtriCure.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral Anticoagulants.
Primary Outcome
The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator: * Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip * Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke * Major bleeding (defined as requiring re-operation and/or transfusion (\> 2 U packed red blood cells (PRBC)) wi
Conditions Studied
Interventions
- DEVICE AtriClip LAA Exclusion Device
Study Locations (7)
California
- St. Helena Hospital - St. Helena
Florida
- Mercy Hospital - Miami
Indiana
- Franciscan St. Francis Health - Indianapolis
Ohio
- Good Samaritan Hospital - Cincinnati
Texas
- Houston Methodist Hospital - Houston
Virginia
- University of Virginia - Charlottesville
Wisconsin
- Aspirus - Wausau
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT01997905 record still lists
NCT01997905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which AtriClip LAA Exclusion Device is the first listed.
NCT01997905 lists 7 locations in 7 states (California, Florida, Indiana).
Frequently Asked Questions
What is clinical trial NCT01997905 about?
NCT01997905 is a clinical study titled "Stroke Feasibility Study". This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage. The purpose is for evaluation of Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation who are unable to take Oral...
What is the current status of trial NCT01997905?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2014-01. Estimated completion is 2015-08.
What conditions does trial NCT01997905 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Afib.
What interventions are being tested in trial NCT01997905?
The interventions under investigation include: AtriClip LAA Exclusion Device (DEVICE).
Who is sponsoring clinical trial NCT01997905?
This trial is sponsored by AtriCure, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01997905 being conducted?
This trial has 7 study locations across California, Florida, Indiana, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01997905's enrollment target sits among peer trials
13 198th of 202 higher than 4 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation 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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