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

N/ACompletedNCT01920295

Yuksek Ihtisas Hospital60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Paroxysmal Atrial Fibrillation

Interventions

Cryoballoon ablationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * paroxysmal atrial fibrillation, symptomatic Exclusion Criteria: * atrial fibrillation other than PAF, asymptomatic, previous AF ablation

Locations (1)

Yuksek Ihtisas Heart-Education and Research Hospital

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)

At prespecified interval of 12th 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

Time frame: 12 months from the procedure

Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)

At prespecified interval of 3rd 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

Time frame: 3 months from the procedure

Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)

At prespecified interval of 6th 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

Time frame: 6 months from the procedure

Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)

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

Time frame: 9 months from the procedure

Data from ClinicalTrials.gov

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