Back to resultsCryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cryoballoon ablation
Radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Previous failed first radiofrequency ablation procedure (only circumferential PV isolation without linear lesions) in patients referred for second catheter ablation of AF
- > 3 months after first PVI
Exclusion Criteria:
- Congestive heart failure
- Ejection fraction <35%
- Left atrial diameter >60 mm
Sites / Locations
- The Valley Health System and Columbia University College of Physicians & Surgeons
- State Research Institute of Circulation Pathology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cryoballoon group
RF group
Arm Description
Outcomes
Primary Outcome Measures
Recurrence of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a second ablation procedure
Secondary Outcome Measures
Percentage of complication after procedure between two groups
Full Information
NCT ID
NCT01611701
First Posted
May 25, 2012
Last Updated
June 1, 2012
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT01611701
Brief Title
Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF
Official Title
Cryoballoon Ablation of Pulmonary Veins After Failed Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this prospective randomized double-blind study was to compare the efficacy and safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after failed first radiofrequency ablation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryoballoon group
Arm Type
Active Comparator
Arm Title
RF group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
cryoballoon ablation
Intervention Description
In Cryo group, 28mm balloon was introduced into the PV ostium with the best possible occlusion of the PV. Every step was controlled by fluoroscopy. Cryoenergy was applied for maximal 6 minutes per application for 2 times, resulting in a circumferential ablation lesion. Before the right superior vein was treated, a quadripolar catheter was placed in the superior vena cava to continuously stimulate the right phrenic nerve during cryoapplication. The application was stopped immediately in the case of diminished diaphragm movements.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
n RF group, reisolation of the PV was performed by identifying the breakthrough site. Radiofrequency energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s.
Primary Outcome Measure Information:
Title
Recurrence of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a second ablation procedure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percentage of complication after procedure between two groups
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous failed first radiofrequency ablation procedure (only circumferential PV isolation without linear lesions) in patients referred for second catheter ablation of AF
> 3 months after first PVI
Exclusion Criteria:
Congestive heart failure
Ejection fraction <35%
Left atrial diameter >60 mm
Facility Information:
Facility Name
The Valley Health System and Columbia University College of Physicians & Surgeons
City
New York
State/Province
New York
Country
United States
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
23210695
Citation
Pokushalov E, Romanov A, Artyomenko S, Baranova V, Losik D, Bairamova S, Karaskov A, Mittal S, Steinberg JS. Cryoballoon versus radiofrequency for pulmonary vein re-isolation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2013 Mar;24(3):274-9. doi: 10.1111/jce.12038. Epub 2012 Dec 4.
Results Reference
derived
Links:
URL
http://meshalkin.ru
Description
State Research Institute of Circulation Pathology Official Site
Learn more about this trial
Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF
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