Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: Cryoballoon ablation

• Registration Number: NCT01920295
• Lead Sponsor: Yuksek Ihtisas Hospital

Brief Summary

Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Study First Submitted: 2013-05-01
• Status Verified: 2013-08
• Study First Submitted QC: 2013-08-07
• Last Update Submitted: 2013-08-07
• Study First Posted: 2013-08-09
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• paroxysmal atrial fibrillation, symptomatic

Exclusion Criteria

• atrial fibrillation other than PAF, asymptomatic, previous AF ablation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoballoon ablation	Cryoballoon ablation	Cryoballoon ablation
Cryoballoon after medical therapy	Cryoballoon ablation	Cryoballoon ablation
Cryoballoon as first-line therapy	Cryoballoon ablation	Cryoballoon ablation
Cryoballoon after failed drug therapy	Cryoballoon ablation	Cryoballoon ablation

Primary Outcome Measures

Name	Time	Method
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)	9 months from the procedure	At prespecified interval of 9th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring

Trial Locations

Locations (1)

Yuksek Ihtisas Heart-Education and Research Hospital; 🇹🇷 Ankara, Turkey