Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation
Public ClinicalTrials.gov record NCT01898221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 persistent AF after a failed PVAI will be randomized to either PVAI or VOM-PV as their repeat procedure. End points will include freedom from symptomatic or electrocardiographic AF after 12-15 months.
Study identification
- NCT ID
- NCT01898221
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 343 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2013 (Actual)
- Primary completion
- Dec 2019 (Actual)
- Completion
- Dec 2019 (Actual)
- Last update posted
- Aug 21, 2025
2013 – 2019
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Heart Rhythm Center | Phoenix | Arizona | 85013 | — |
| USC Los Angeles - Keck Hopsital | Los Angeles | California | 90033 | — |
| San Diego Cardiac Center | San Diego | California | 92123 | — |
| University of Colorado School of Medicince, Denver | Denver | Colorado | 80045 | — |
| Emory University Hospital | Atlanta | Georgia | 30308 | — |
| KUMC Research Institute | Kansas City | Kansas | 66160 | — |
| St. Luke's Hospital Duluth | Duluth | Minnesota | 55802 | — |
| Texas Cardiac Arrythmia Research Foundation | Austin | Texas | 78705 | — |
| BCM/CHI St. Luke's Hospital | Houston | Texas | 77030 | — |
| Houston Methodist | Houston | Texas | 77030 | — |
| Houston VAMC | Houston | Texas | 77030 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23292 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01898221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01898221 live on ClinicalTrials.gov.