NCT01038115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 19, 2014

Status Verified

March 1, 2011

Enrollment Period

5.3 years

First QC Date

December 21, 2009

Last Update Submit

February 17, 2014

Conditions

Atrial Fibrillation

Keywords

Catheter Ablation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (3)

Cryoballoon

ACTIVE COMPARATOR
Procedure: Atrial fibrillation ablation

Radiofrequency

ACTIVE COMPARATOR
Procedure: Atrial fibrillation ablation

Cryoballoon + Radiofrequency together

ACTIVE COMPARATOR
Procedure: Atrial fibrillation ablation

Interventions

Atrial fibrillation ablationPROCEDURE

Comparison of three different techniques for pulmonary vein isolation

CryoballoonCryoballoon + Radiofrequency togetherRadiofrequency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Significant valvular disease
  • Previous left atrial ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts and the London NHS Trust

London, London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26727045DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2009

First Posted

December 23, 2009

Study Start

September 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 19, 2014

Record last verified: 2011-03

Locations

GB(1)