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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01173796
First received: June 21, 2010
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Perimitral Flutter
 Procedure: catheter ablation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total number of hospitalizations during the study period Change in quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PMFL ablation
Radio-frequency catheter ablation of the mitral isthmus only
 Procedure: catheter ablation
perimitral flutter ablation by blocking the mitral isthmus
Experimental: Repeat PVAI and triggers ablation
cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
 Procedure: catheter ablation
cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173796

Locations
United States, Texas
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Investigators
Principal Investigator: Andrea Natale, MD Texas cardia Arrhythmia Institute, St.David's Medical center
  More Information

No publications provided by Texas Cardiac Arrhythmia Research Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01173796     History of Changes
Other Study ID Numbers: TCAI-PROPOSE
Study First Received: June 21, 2010
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013