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Completed

NCT Number: NCT01173796

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter ablation

Procedure

perimitral flutter ablation by blocking the mitral isthmus

Primary outcomes

  1. Freedom from AF/ flutter/ tachycardia off antiarrhythmic therapy

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Texas Cardiac Arrhythmia Research Foundation

Other

Registry information

Acronym: PROPOSE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 2, 2010
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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