Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF
1 other identifier
interventional
80
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 25, 2012
CompletedFirst Posted
Study publicly available on registry
June 5, 2012
CompletedJune 5, 2012
June 1, 2012
1.3 years
May 25, 2012
June 1, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a second ablation procedure
1 year
Secondary Outcomes (1)
Percentage of complication after procedure between two groups
1 year
Study Arms (2)
Cryoballoon group
ACTIVE COMPARATORRF group
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Congestive heart failure
- Ejection fraction \<35%
- Left atrial diameter \>60 mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Valley Health System and Columbia University College of Physicians & Surgeons
New York, New York, United States
State Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
Related Publications (1)
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.
PMID: 23210695DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2012
First Posted
June 5, 2012
Study Start
October 1, 2009
Primary Completion
January 1, 2011
Study Completion
February 1, 2012
Last Updated
June 5, 2012
Record last verified: 2012-06