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Study Comparing Pulmonary Vein Isolation With the Cryoballoon, Radiofrequency Energy, or Both in the Treatment of Atrial Fibrillation (AF) (Cryo Vs RFA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Barts & The London NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01038115
First received: December 21, 2009
Last updated: March 21, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
 Procedure: Atrial fibrillation ablation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Study Comparing Pulmonary Vein Isolation Using the Occluding Cryoballoon, Conventional Radiofrequency Energy, or Both in the Treatment of Atrial Fibrillation (AF).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Freedom from AF after a single procedure at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Freedom from AF or any other atrial tachyarrhythmia lasting > 30 seconds (symptomatic or not) at 6 months following a single ablation procedure.


Secondary Outcome Measures:
  • 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. [ Time Frame: 0-12 months post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 246
Study Start Date: September 2008
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cryoballoon Procedure: Atrial fibrillation ablation
Comparison of three different techniques for pulmonary vein isolation
Active Comparator: Radiofrequency Procedure: Atrial fibrillation ablation
Comparison of three different techniques for pulmonary vein isolation
Active Comparator: Cryoballoon + Radiofrequency together Procedure: Atrial fibrillation ablation
Comparison of three different techniques for pulmonary vein isolation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038115

Contacts
Contact: Richard J Schilling, FRCP MD 02076018639 victoria.baker@bartsandthelondon.nhs.uk

Locations
United Kingdom
Barts and the London NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Contact: Richard J Schilling, FRCP MD     02076018639     victoria.baker@bartsandthelondon.nhs.uk    
Principal Investigator: Richard J Schilling, FRCP MD            
Sponsors and Collaborators
Barts & The London NHS Trust
  More Information

No publications provided

Responsible Party: Professor Richard Schilling, Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01038115     History of Changes
Other Study ID Numbers: 005841
Study First Received: December 21, 2009
Last Updated: March 21, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Barts & The London NHS Trust:
Catheter Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013