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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01920295

Acronym

C-frost

Enrollment

Registered

2013-08-09

Start date

2011-01-31

Completion date

2013-04-30

Last updated

2013-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Brief summary

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

Interventions

DEVICECryoballoon ablation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* paroxysmal atrial fibrillation, symptomatic

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)	12 months from the procedure	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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026