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OpenTrials
Completed

NCT Number: NCT01920295

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

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

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yuksek Ihtisas Heart-Education and Research Hospital

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • paroxysmal atrial fibrillation, symptomatic

Exclusion criteria

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

Treatment and study plan

Cryoballoon ablation

Device

Primary outcomes

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

    Time frame: 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

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

    Time frame: 3 months from the procedure

    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

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

    Time frame: 6 months from the procedure

    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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yuksek Ihtisas Hospital

Other

Registry information

Acronym: C-frost

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2013
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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