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NCT05434650 · ClinicalTrials.gov registry record
Abbott Atrial Fibrillation Post Approval Study
A clinical trial of Atrial Arrhythmia and Atrial Tachycardia, sponsored by Abbott Medical Devices.
- Active
- Registry status
- 200
- Enrollment target
- 20
- Study locations
NCT05434650: Active study of Atrial Arrhythmia and Atrial Tachycardia, sponsored by Abbott Medical Devices.
NCT05434650 is a study of Atrial Arrhythmia and Atrial Tachycardia that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 200 participants, below the 235-participant average among 4 other Atrial Arrhythmia trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05434650, a study of Atrial Arrhythmia and Atrial Tachycardia, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
This post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g. TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)) for the treatment of AF.
Primary Outcome
AF recurrence is defined as: 1. Documented AF/atrial flutter (AFL)/atrial tachycardia (AT) episodes of \> 30 seconds duration following the blanking period 2. Repeat ablation for AF/AFL/AT following the blanking period 3. Cardioversion (electrical or pharmaceutical) for the treatment of AF following the blanking period 4. A new Class I/III AAD or a previously failed Class I/III AAD at a dose greater than the highest historical dose for AF is needed following the blanking period
Conditions Studied
Interventions
- DEVICE electrophysiology study and ablation with an Abbott Ablation Catheter
Study Locations (20)
California
- Eisenhower Medical Center - Rancho Mirage
- Sequoia Hospital - Redwood City
Massachusetts
- Brigham & Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Tennessee
- Erlanger Medical Center - Chattanooga
- Centennial Medical Center - Nashville
Virginia
- Sentara Norfolk General Hospital - Norfolk
- Chippenham Hospital - Richmond
Alabama
- Heart Center Research, LLC. - Huntsville
Arkansas
- Arkansas Cardiology - Little Rock
Georgia
- Northside Hospital - Atlanta
Louisiana
- Ochsner Medical Center - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-10-21 |
| Est. Completion | 2026-11-30 |
What the registry record for NCT05434650 still lists
NCT05434650 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 235-participant average among 4 other Atrial Arrhythmia trials with a reported enrollment target (15% lower).
The record links to 3 conditions, with Atrial Arrhythmia appearing as the primary indexed condition, and to 1 intervention - of which electrophysiology study and ablation with an Abbott Ablation Catheter is the first listed.
NCT05434650 names 20 study sites across 16 states, led by California, Massachusetts, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05434650 about?
NCT05434650 is a clinical study titled "Abbott Atrial Fibrillation Post Approval Study". This post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g. TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)) for the treatment of...
What is the current status of trial NCT05434650?
This trial is currently active not recruiting. The enrollment target is 200 participants. The study started on 2022-10-21. Estimated completion is 2026-11-30.
What conditions does trial NCT05434650 study?
This clinical trial studies the following conditions: Atrial Arrhythmia, Atrial Tachycardia, Atrium; Fibrillation.
What interventions are being tested in trial NCT05434650?
The interventions under investigation include: electrophysiology study and ablation with an Abbott Ablation Catheter (DEVICE).
Who is sponsoring clinical trial NCT05434650?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05434650 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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