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

June 21, 2010
July 10, 2012
March 2010
September 2011   (final data collection date for primary outcome measure)
Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01173796 on ClinicalTrials.gov Archive Site
Total number of hospitalizations during the study period Change in quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes
Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Perimitral Flutter
  • 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: PMFL ablation
    Radio-frequency catheter ablation of the mitral isthmus only
    Intervention: Procedure: catheter ablation
  • Experimental: Repeat PVAI and triggers ablation
    cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
    Intervention: Procedure: catheter ablation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01173796
TCAI-PROPOSE
No
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
Texas Cardiac Arrhythmia Research Foundation
Not Provided
Principal Investigator: Andrea Natale, MD Texas cardia Arrhythmia Institute, St.David's Medical center
Texas Cardiac Arrhythmia Research Foundation
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP