Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Miguel X. Valderrabano, MD
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH); The Methodist Hospital Research Institute; The Methodist Hospital System
• Treatments: Ethanol

Criteria

Inclusion Criteria:

1. Patients between the ages of 21 and 85 years

2. 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

3. Resistant or intolerant to at least one class I, II, or III anti arrhythmic drugs (AAD)

4. Patients deemed candidates for radio frequency(RF) ablation of AF

5. Able and willing to comply with pre-, post-, and follow-up requirements.

Exclusion Criteria:

1. Patients with previous PVAI procedure or left heart ablation procedure.

2. Left atrial thrombus.

3. LA diameter greater than 65 mm on long axis parasternal view, or left atrial volume more than 200 cc by MRI or CT.

4. Left ventricular ejection fraction < 30%.

5. Cardiac surgery within the previous 180 days.

6. Expecting cardiac transplantation or other cardiac surgery within 180 days.

7. Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within the previous 90 days.

8. Documented history of a thrombi-embolic event within the previous 90 days.

9. Diagnosed atrial myxoma.

10. Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.

11. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment

12. Women who are pregnant.

13. 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.

14. Creatinine> 2. 5 mg/dl (or > 221 μmol/L, except for patients in dialysis).

15. Unstable angina.

16. Myocardial infarction within the previous 60 days.

17. History of blood clotting or bleeding abnormalities.

18. Contraindication to anticoagulation.

19. Contraindication to computed tomography or MRI procedures.

20. Life expectancy less than 1 year.

21. Uncontrolled heart failure.

22. Presence of an intramural thrombus, tumor, or other abnormality that precludes catheter introduction or positioning.

23. Presence of a condition that precludes vascular access.

24. Institute for Natural Resources (INR) greater than 3. 5 within 24 hours of procedure.

25. Cannot be removed from antiarrhythmic drugs for reasons other than AF.

26. Unwilling or unable to provide informed consent.

27. Current reported alcoholism.

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