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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Perimitral Flutter
• Intervention / Treatment: Procedure: catheter ablation; Procedure: catheter ablation

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States
      • Texas Cardiac Arrhythmia Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PMFL ablation; Radio-frequency catheter ablation of the mitral isthmus only	Procedure: catheter ablation; perimitral flutter ablation by blocking the mitral isthmus; Procedure: catheter ablation; cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
EXPERIMENTAL: Repeat PVAI and triggers ablation; cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers	Procedure: catheter ablation; perimitral flutter ablation by blocking the mitral isthmus; Procedure: catheter ablation; cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Total number of hospitalizations during the study period Change in quality of life	12 months

Collaborators and Investigators

• Sponsor: Texas Cardiac Arrhythmia Research Foundation
• Investigators: Principal Investigator: Andrea Natale, MD, Texas cardia Arrhythmia Institute, St.David's Medical center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: June 21, 2010
• First Submitted That Met QC Criteria: July 29, 2010
• First Posted (ESTIMATE): August 2, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 10, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: TCAI-PROPOSE