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NCT03646643 · ClinicalTrials.gov registry record · NA
Prospective Elimination Of Distal Coronary Sinus-Left Atrial Connections for Atrial Fibrillation Ablation Trial
A NA study of Atrial Fibrillation and Arrhythmias, Cardiac, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03646643: Completed NA study of Atrial Fibrillation and Arrhythmias, Cardiac, sponsored by University of Pennsylvania.
NCT03646643 is a NA study of Atrial Fibrillation and Arrhythmias, Cardiac that has completed, run by University of Pennsylvania. The registered enrollment target is 35 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03646643, a NA study of Atrial Fibrillation and Arrhythmias, Cardiac, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting millions of people in the US and around the world. Over the last 20 years, catheter based AF ablation has been widely adopted offering improved symptom control for many patients worldwide. However, long-term success rates remain suboptimal. Prior work indicates that distal connections between coronary sinus musculature and the left atrium exist and provide a substrate for single or multiple reentry beats as a trigger for atrial fibrillation. In this trial, the investigators will examine the efficacy of elimination of distal connection(s) between coronary sinus and left atrial musculature for suppression of recurrent atrial arrhythmias.
Primary Outcome
The primary endpoint of the study is recurrence rate of atrial arrhythmia following ablation. The primary endpoint will be assessed using survival statistical models measuring time to failure among the two study arms. Failure is defined as a non-self-terminating bout of atrial fibrillation, atrial flutter, or atrial tachycardia \>30 seconds in duration following the 90-day post-ablation blanking period. If no AF occurs during the study period, censoring will occur at 180±45 days post-ablation.
Conditions Studied
Interventions
- PROCEDURE Standard Atrial fibrillation ablation
- PROCEDURE Coronary sinus to left atrium connection elimination
Study Locations (1)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-08-18 |
| Est. Completion | 2021-09-22 |
| Phase | NA |
What the finished NCT03646643 record still lists
NCT03646643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Standard Atrial fibrillation ablation is the first listed.
NCT03646643 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03646643 about?
NCT03646643 is a clinical study titled "Prospective Elimination Of Distal Coronary Sinus-Left Atrial Connections for Atrial Fibrillation Ablation Trial". Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting millions of people in the US and around the world. Over the last 20 years, catheter based AF ablation has been widely adopted offering improved symptom control for many patients worldwide. However, long-term success rates remai...
What is the current status of trial NCT03646643?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2018-08-18. Estimated completion is 2021-09-22.
What conditions does trial NCT03646643 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Arrhythmias, Cardiac.
What interventions are being tested in trial NCT03646643?
The interventions under investigation include: Standard Atrial fibrillation ablation (PROCEDURE), Coronary sinus to left atrium connection elimination (PROCEDURE).
Who is sponsoring clinical trial NCT03646643?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03646643 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03646643's enrollment target sits among peer trials
35 185th of 202 higher than 18 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
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