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NCT01660100 · ClinicalTrials.gov registry record · NA
Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation
A NA study of Atrial Fibrillation, sponsored by Texas Cardiac Arrhythmia Research Foundation.
- Completed
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 1
- Study location
NCT01660100: Completed NA study of Atrial Fibrillation, sponsored by Texas Cardiac Arrhythmia Research Foundation.
NCT01660100 is a NA study of Atrial Fibrillation that has completed, run by Texas Cardiac Arrhythmia Research Foundation. The registered enrollment target is 400 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01660100, a NA study of Atrial Fibrillation, has completed, sponsored by Texas Cardiac Arrhythmia Research Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF) ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation plus left atrial posterior wall isolation is proven by a repeat procedure. The study will be conducted in patients with different types of AF: paroxysmal AF (PAF) and non-PAF (Persistent AF and Long Standing Persistent AF). Hypothesis: In addition to permanent pulmonary vein antrum isolation, proven isolation of left atrial posterior wall is associated with more freedom from atrial arrhythmia at long-term follow-up after atrial fibrillation ablation, especially in non-PAF patients.
Primary Outcome
"Procedure success" is defined as freedom from atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) off antiarrhythmic drug during follow-up after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven. "Procedure failure" is defined as atrial arrhythmia recurrence during follow-up after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven.
Conditions Studied
Interventions
- PROCEDURE Pulmonary vein antrum isolation (PVAI)
- PROCEDURE PVAI plus left atrial posterior wall (LAPW) isolation
Study Locations (1)
Texas
- Texas Cardiac Arrhythmia Institute - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-12 |
| Phase | NA |
What the finished NCT01660100 record still lists
NCT01660100 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Pulmonary vein antrum isolation (PVAI) is the first listed.
NCT01660100 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01660100 about?
NCT01660100 is a clinical study titled "Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation". Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF) ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation plus left atrial posterior wall isolation is proven by a repeat procedure. The study will be conducted in patients wit...
What is the current status of trial NCT01660100?
This trial is currently completed. It is a NA study. The enrollment target is 400 participants. The study started on 2012-07. Estimated completion is 2016-12.
What conditions does trial NCT01660100 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT01660100?
The interventions under investigation include: Pulmonary vein antrum isolation (PVAI) (PROCEDURE), PVAI plus left atrial posterior wall (LAPW) isolation (PROCEDURE).
Who is sponsoring clinical trial NCT01660100?
This trial is sponsored by Texas Cardiac Arrhythmia Research Foundation, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01660100 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01660100's enrollment target sits among peer trials
400 69th of 202 higher than 132 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
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