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

NCT ID: NCT01173796

Last Updated: 2012-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-09-30

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.

Conditions

Atrial Fibrillation; Perimitral Flutter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PMFL ablation

Radio-frequency catheter ablation of the mitral isthmus only

Group Type: EXPERIMENTAL

catheter ablation

Intervention Type: PROCEDURE

perimitral flutter ablation by blocking the mitral isthmus

Repeat PVAI and triggers ablation

cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers

Group Type: EXPERIMENTAL

catheter ablation

Intervention Type: PROCEDURE

cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers

Interventions

catheter ablation

perimitral flutter ablation by blocking the mitral isthmus

Intervention Type: PROCEDURE

catheter ablation

cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Andrea Natale

Executive Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

Texas cardia Arrhythmia Institute, St.David's Medical center

Locations

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Countries

United States

References

Bai R, Di Biase L, Mohanty P, Dello Russo A, Casella M, Pelargonio G, Themistoclakis S, Mohanty S, Elayi CS, Sanchez J, Burkhardt JD, Horton R, Gallinghouse GJ, Bailey SM, Bonso A, Beheiry S, Hongo RH, Raviele A, Tondo C, Natale A. Ablation of perimitral flutter following catheter ablation of atrial fibrillation: impact on outcomes from a randomized study (PROPOSE). J Cardiovasc Electrophysiol. 2012 Feb;23(2):137-44. doi: 10.1111/j.1540-8167.2011.02182.x. Epub 2011 Sep 28.

Reference Type: DERIVED

PMID: 21955215 (View on PubMed)

Other Identifiers

TCAI-PROPOSE

Identifier Type: -

Identifier Source: org_study_id