Status:
COMPLETED
Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Ventricular Tachycardia
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 mo...
Detailed Description
Although the risk of stroke is comparable in persistent and paroxysmal AF, the prevalence of persistent AF increases dramatically with increasing age, and thus is an overall more significant cause of ...
Eligibility Criteria
Inclusion
- Patients between the ages of 21 and 85 years
- Diagnosed with symptomatic persistent AF Documentation of history of AF for at least 6 months AF not spontaneously converting to sinus rhythm, persisting for ≥7 days Sinus rhythm after cardioversion is NOT exclusion, provided that≥2 episodes of persistent AF occurred in the previous 6 months
- Resistant or intolerant to at least one class I, II, or III anti arrhythmic drugs (AAD)
- Patients deemed candidates for radio frequency(RF) ablation of AF
- Able and willing to comply with pre-, post-, and follow-up requirements.
Exclusion
- Patients with previous PVAI procedure or left heart ablation procedure.
- Left atrial thrombus.
- LA diameter greater than 65 mm on long axis parasternal view, or left atrial volume more than 200 cc by MRI or CT.
- Left ventricular ejection fraction \< 30%.
- Cardiac surgery within the previous 180 days.
- Expecting cardiac transplantation or other cardiac surgery within 180 days.
- Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within the previous 90 days.
- Documented history of a thrombi-embolic event within the previous 90 days.
- Diagnosed atrial myxoma.
- Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- Women who are pregnant.
- Acute illness or active infection at time of index procedure documented by either pain, fever, drainage, positive culture and/or leukocytosis (WBC \> 11. 000 mm3) for which antibiotics have been or will be prescribed.
- Creatinine\> 2. 5 mg/dl (or \> 221 μmol/L, except for patients in dialysis).
- Unstable angina.
- Myocardial infarction within the previous 60 days.
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation.
- Contraindication to computed tomography or MRI procedures.
- Life expectancy less than 1 year.
- Uncontrolled heart failure.
- Presence of an intramural thrombus, tumor, or other abnormality that precludes catheter introduction or positioning.
- Presence of a condition that precludes vascular access.
- Institute for Natural Resources (INR) greater than 3. 5 within 24 hours of procedure.
- Cannot be removed from antiarrhythmic drugs for reasons other than AF.
- Unwilling or unable to provide informed consent.
- Current reported alcoholism.
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Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT01898221
Start Date
October 1 2013
End Date
December 1 2019
Last Update
August 21 2025
Active Locations (12)
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1
Arizona Heart Rhythm Center
Phoenix, Arizona, United States, 85013
2
USC Los Angeles - Keck Hopsital
Los Angeles, California, United States, 90033
3
San Diego Cardiac Center
San Diego, California, United States, 92123
4
University of Colorado School of Medicince, Denver
Denver, Colorado, United States, 80045