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NCT01898221 · ClinicalTrials.gov registry record · Phase 3
Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation
A Phase 3 study, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 343
- Enrollment target
NCT01898221 is a Phase 3 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 343 participants.
The verdict
NCT01898221, a Phase 3 study, has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 343 participants
- Enrollment target
Study Summary
The broad, long-term objective of this project is to evaluate the therapeutic value of vein of Marshall (VOM) ethanol infusion when added to catheter ablation of atrial fibrillation (AF). AF is the most common sustained arrhythmia in adults, and it is a leading cause of stroke, disability and increased mortality. Catheter ablation - pulmonary vein (PV) antral isolation (PVAI)- can lead to cure, but is best suited for paroxysmal AF, in which ectopic beats arising from the pulmonary veins were shown to initiate AF. PVAI success is lower in persistent AF, in which the role of the cardiac autonomic system, particularly the intrinsic cardiac ganglia, is being increasingly recognized. Expanding the ablation lesions to include greater areas the left atrial (LA) anatomy marginally improves outcomes, but also leads to increases in procedural complexity and duration, need of repeat procedures, and complications such as atrial flutters, particularly perimitral flutter (PMF). The investigators have developed a technique to perform rapid ablation of atrial tissues in AF using ethanol infusion in the vein of Marshall (VOM), and have shown: 1) Effective, rapid and safe tissue ablation of LA tissue neighboring the LA ridge and left inferior PV; 2) Regional LA vagal denervation by reaching the intrinsic cardiac ganglia; and 3) Facilitation of cure of PMF by ablating most of the mitral isthmus. The investigators propose to evaluate outcomes differences yielded by VOM ethanol when added to conventional PVAI. The specific aims are: #1.To assesses the impact of VOM ethanol infusion in procedure success when added to de novo catheter ablation of persistent AF. The investigators will randomize patients with persistent AF undergoing a first AF ablation to standard PVAI vs. a combined VOM ethanol infusion plus PVAI (VOM-PV) #2. To assess the impact of VOM ethanol infusion added to repeat catheter ablation of recurrent AF after a failed ablation. Patients undergoing a repeat procedure for p
Interventions
- DRUG Ethanol
- PROCEDURE Ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2013-10 |
| Est. Completion | 2019-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01898221
The ClinicalTrials.gov registry entry for NCT01898221 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 343 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ethanol is the first listed.
NCT01898221 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01898221 about?
NCT01898221 is a clinical study titled "Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation". The broad, long-term objective of this project is to evaluate the therapeutic value of vein of Marshall (VOM) ethanol infusion when added to catheter ablation of atrial fibrillation (AF). AF is the most common sustained arrhythmia in adults, and it is a leading cause of stroke, disability and increa...
What is the current status of trial NCT01898221?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 343 participants. The study started on 2013-10. Estimated completion is 2019-12.
What interventions are being tested in trial NCT01898221?
The interventions under investigation include: Ethanol (DRUG), Ablation (PROCEDURE).
Who is sponsoring clinical trial NCT01898221?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
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