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

Primary Purpose

Atrial Fibrillation, Perimitral Flutter

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
catheter ablation
catheter ablation
Sponsored by
Texas Cardiac Arrhythmia Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Cardiac Arrhythmia Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PMFL ablation

Repeat PVAI and triggers ablation

Arm Description

Radio-frequency catheter ablation of the mitral isthmus only

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

Outcomes

Primary Outcome Measures

Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy

Secondary Outcome Measures

Total number of hospitalizations during the study period Change in quality of life

Full Information

First Posted
June 21, 2010
Last Updated
July 10, 2012
Sponsor
Texas Cardiac Arrhythmia Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01173796
Brief Title
Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes
Acronym
PROPOSE
Official Title
Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Perimitral Flutter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PMFL ablation
Arm Type
Experimental
Arm Description
Radio-frequency catheter ablation of the mitral isthmus only
Arm Title
Repeat PVAI and triggers ablation
Arm Type
Experimental
Arm Description
cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
Intervention Type
Procedure
Intervention Name(s)
catheter ablation
Intervention Description
perimitral flutter ablation by blocking the mitral isthmus
Intervention Type
Procedure
Intervention Name(s)
catheter ablation
Intervention Description
cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
Primary Outcome Measure Information:
Title
Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Total number of hospitalizations during the study period Change in quality of life
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas cardia Arrhythmia Institute, St.David's Medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21955215
Citation
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.
Results Reference
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Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes

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