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Clinical Trials/NCT01038115
NCT01038115CompletedPhase 4

A Randomised Study Comparing Pulmonary Vein Isolation Using the Occluding Cryoballoon, Conventional Radiofrequency Energy, or Both in the Treatment of Atrial Fibrillation (AF).

Barts & The London NHS Trust1 site in 1 country237 target enrollmentStarted: September 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
237
Locations
1
Primary Endpoint
Freedom from AF after a single procedure at 12 months.

Study Overview

Brief Summary

The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation, or both together in the treatment of paroxysmal AF.

The hypotheses for this study are (1) that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of paroxysmal AF and is associated with a better long term outcome, and (2) that use of both cryothermy and RF in combination is as effective and safe as using either radiofrequency energy or cryothermy alone and is associated with a better long term outcome.

Detailed Description

Pulmonary vein isolation is an important treatment for patients with atrial fibrillation (AF), particularly those in whom antiarrhythmic drugs are ineffective or cannot be tolerated. One method involves the use of radiofrequency energy and 3-D mapping system to produce a series of lesions (small burn areas) within the heart. Another method involves passing a balloon (called a cryoballoon) into the heart and freezing the parts of the heart muscle that the veins drain into. Both methods appear to be effective from known data. However, it is not known if use of either method alone or both together is the most effective. We aim to perform a prospective, randomized clinical trial comparing these three strategies.

Substudy 1: Use of cardiac MRI to evaluate ablation lesions. Some patients will also be asked to undergo an MRI scan of the heart before the ablation procedure, and again at three months and one year following the procedure. This will allow us to examine the potential role for MRI in imaging scar tissue formed by the ablation, and help us understand the time course of scar formation and changes to that part of the heart following the ablation.

Substudy 2: Platelet reactivity and activation in AF, and the impact of curative ablation. Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet reactivity and activation are affected by AF compared to established normal ranges, and whether curative ablation impacts on this.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients with documented paroxysmal AF on at least 2 occasions and accepted for catheter ablation.

Exclusion Criteria

  • •Significant valvular disease
  • •Previous left atrial ablation

Arms & Interventions

Cryoballoon

Active Comparator

Intervention: Atrial fibrillation ablation (Procedure)

Radiofrequency

Active Comparator

Intervention: Atrial fibrillation ablation (Procedure)

Cryoballoon + Radiofrequency together

Active Comparator

Intervention: Atrial fibrillation ablation (Procedure)

Outcomes

Primary Outcomes

Freedom from AF after a single procedure at 12 months.

Time Frame: 12 months

Freedom from AF or any other atrial tachyarrhythmia lasting \> 30 seconds (symptomatic or not) at 12 months following a single ablation procedure.

Secondary Outcomes

  • Complication rates, costs, fluoroscopy times, radiation exposure, and long term success. MRI substudy: sensitivity & specificity for determining ablation lesions. Platelet substudy: Platelet activation post ablation compared to baseline.(0-12 months post procedure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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