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

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ClinicalTrials.gov Identifier: NCT01920295
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : August 9, 2013
Sponsor:
Information provided by (Responsible Party):
Serkan Cay, 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

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: Cryoballoon ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cryoballoon ablation
Cryoballoon ablation
Device: Cryoballoon ablation
Active Comparator: Cryoballoon after medical therapy
Cryoballoon ablation
Device: Cryoballoon ablation
Experimental: Cryoballoon as first-line therapy
Cryoballoon ablation
Device: Cryoballoon ablation
Active Comparator: Cryoballoon after failed drug therapy
Cryoballoon ablation
Device: Cryoballoon ablation



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • paroxysmal atrial fibrillation, symptomatic

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920295


Locations
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Turkey
Yuksek Ihtisas Heart-Education and Research Hospital
Ankara, Turkey, 06100
Sponsors and Collaborators
Yuksek Ihtisas Hospital

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Responsible Party: Serkan Cay, Associate Professor, Yuksek Ihtisas Hospital
ClinicalTrials.gov Identifier: NCT01920295     History of Changes
Other Study ID Numbers: 3196568
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes