Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy (C-frost)

Yuksek Ihtisas Hospital

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: Cryoballoon ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01920295

3196568

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• paroxysmal atrial fibrillation, symptomatic

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

Cryoballoon ablation

Experimental group

Description:

Cryoballoon ablation

Treatment:

Device: Cryoballoon ablation

Cryoballoon after medical therapy

Active Comparator group

Description:

Cryoballoon ablation

Treatment:

Device: Cryoballoon ablation

Cryoballoon as first-line therapy

Experimental group

Description:

Cryoballoon ablation

Treatment:

Device: Cryoballoon ablation

Cryoballoon after failed drug therapy

Active Comparator group

Description:

Cryoballoon ablation

Treatment:

Device: Cryoballoon ablation