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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Atrial fibrillation ablation

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 Type: Interventional
• Enrollment (Actual): 237
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Barts and The London NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from AF after a single procedure at 12 months.	Freedom from AF or any other atrial tachyarrhythmia lasting > 30 seconds (symptomatic or not) at 12 months following a single ablation procedure.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust

Publications and helpful links

General Publications

• Hunter RJ, Baker V, Finlay MC, Duncan ER, Lovell MJ, Tayebjee MH, Ullah W, Siddiqui MS, McLEAN A, Richmond L, Kirkby C, Ginks MR, Dhinoja M, Sporton S, Earley MJ, Schilling RJ. Point-by-Point Radiofrequency Ablation Versus the Cryoballoon or a Novel Combined Approach: A Randomized Trial Comparing 3 Methods of Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation (The Cryo Versus RF Trial). J Cardiovasc Electrophysiol. 2015 Dec;26(12):1307-14. doi: 10.1111/jce.12846. Epub 2015 Nov 25.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: December 21, 2009
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (ESTIMATE): December 23, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 17, 2014
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Catheter Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 005841