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NCT04356040 · ClinicalTrials.gov registry record · NA
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
A NA study of Paroxysmal Atrial Fibrillation, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 355
- Enrollment target
- 20
- Study locations
NCT04356040: Completed NA study of Paroxysmal Atrial Fibrillation, sponsored by Abbott Medical Devices.
NCT04356040 is a NA study of Paroxysmal Atrial Fibrillation that has completed, run by Abbott Medical Devices. The registered enrollment target is 355 participants, below the 844-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04356040, a NA study of Paroxysmal Atrial Fibrillation, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 355 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).
Primary Outcome
Tthe rate of device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80 days of initial procedure) that are defined below: * Atrio-esophageal fistula1 * Cardiac tamponade/perforation1 * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis1 * Stroke/cerebrovascu
Conditions Studied
Interventions
- DEVICE TactiFlex SE
- DEVICE TactiFlex SE - High Standard Power
Study Locations (20)
California
- Mills-Peninsula Medical Center - Burlingame
- Scripps Health - La Jolla
- University of California at San Diego (UCSD) Medical Center - San Diego
Arkansas
- St. Bernards Medical Center - Jonesboro
- Arkansas Heart Hospital - Little Rock
Idaho
- St. Luke's Regional Medical Center - Boise
- Kootenai Heart Clinics - Coeur d'Alene
Mississippi
- Jackson Heart Clinic - Jackson
- North Mississippi Medical Center - Tupelo
Alabama
- Affinity Cardiovascular Specialists, LLC - Birmingham
Colorado
- South Denver Cardiology Associates PC - Littleton
Florida
- AdventHealth Orlando - Orlando
Georgia
- Piedmont Athens Regional Medical Center - Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2022-07-01 |
| Phase | NA |
What the finished NCT04356040 record still lists
NCT04356040 is an interventional study that assigns participants to a tested intervention. The registered 355 participants enrollment target is mid-sized for trials with a published cap, below the 844-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which TactiFlex SE is the first listed.
NCT04356040 names 20 study sites across 15 states, led by California, Arkansas, Idaho.
Frequently Asked Questions
What is clinical trial NCT04356040 about?
NCT04356040 is a clinical study titled "TactiFlex Paroxysmal Atrial Fibrillation IDE Trial". Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated us...
What is the current status of trial NCT04356040?
This trial is currently completed. It is a NA study. The enrollment target is 355 participants. The study started on 2020-06-29. Estimated completion is 2022-07-01.
What conditions does trial NCT04356040 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation.
What interventions are being tested in trial NCT04356040?
The interventions under investigation include: TactiFlex SE (DEVICE), TactiFlex SE - High Standard Power (DEVICE).
Who is sponsoring clinical trial NCT04356040?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04356040 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04356040's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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