Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes
PROPOSE
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 atrial-fibrillation
Started Mar 2010
Shorter than P25 for phase_3 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 21, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJuly 11, 2012
July 1, 2012
1.5 years
June 21, 2010
July 10, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy
1 year
Secondary Outcomes (1)
Total number of hospitalizations during the study period Change in quality of life
12 months
Study Arms (2)
PMFL ablation
EXPERIMENTALRadio-frequency catheter ablation of the mitral isthmus only
Repeat PVAI and triggers ablation
EXPERIMENTALcardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Related Publications (1)
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.
PMID: 21955215DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Natale, MD
Texas cardia Arrhythmia Institute, St.David's Medical center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Medical Director
Study Record Dates
First Submitted
June 21, 2010
First Posted
August 2, 2010
Study Start
March 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
July 11, 2012
Record last verified: 2012-07