Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes

Phase 3

Completed

• Conditions: Perimitral Flutter; Atrial Fibrillation

• Registration Number: NCT01173796
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

Brief Summary

This prospective, randomized study aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of additional triggers, on procedure outcome.

Detailed Description

Background: In recent years, catheter ablation has been accepted as the treatment-of-choice for drug-refractory atrial fibrillation (AF). It is centered around isolating pulmonary veins (PVs) and its success rate in curing AF is very high (56%-85%) (1). However, despite isolation of this dominant source of triggers, recurrent tachyarrhythmia is the major complication of this procedure with peri-mitral atrial flutter (PMFL) being the most common macro-reentrant arrhythmia in context of AF ablation (2). These often drug-refractory arrhythmias are frequently associated with more severe symptoms than the original AF (3) and warrant the necessity for redo-ablation.

This study aims to compare the impact of two different redo-ablation strategies on the procedure outcome; (1) ablation of the perimitral flutter only and (2) cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers.

Study method: A total number of 65 AF patients presenting for redo-ablation and PMFL will be randomized to perimitral flutter ablation only or cardioversion and re-isolation (PVI) plus ablation of additional triggers. Additional triggers will be identified with the help of post-ablation drug provocation with isoproterenol. Patients will enter a follow-up period of 12 months after the ablation procedure, when they will be monitored for recurrence of arrhythmia detected either by in-clinic or remote device interrogation at 1, 3, 6 and 12 month post-procedure.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-08-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patients with previous AF ablation presenting with PMFL and recurrent AF
• Age: 18- 75 years
• Willingness and ability to give written informed consent
• Therapeutic INR for at least 4 weeks prior to the procedure

Exclusion Criteria

• Reversible causes of AF such as pericarditis and hyperthyroidism
• Documented intra-atrial thrombus, tumor or any other abnormality which prevents easy catheter manipulation
• Enrollment in another clinical study
• Any other terminal illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy	1 year

Secondary Outcome Measures

Name	Time	Method
Total number of hospitalizations during the study period Change in quality of life	12 months

Trial Locations

Locations (1)

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States