Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy (C-frost)
August 7, 2013 updated by: Serkan Cay, Yuksek Ihtisas Hospital
Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ankara, Turkey, 06100
- Yuksek Ihtisas Heart-Education and Research Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- paroxysmal atrial fibrillation, symptomatic
Exclusion Criteria:
- atrial fibrillation other than PAF, asymptomatic, previous AF ablation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cryoballoon ablation
|
|
|
Active Comparator: Cryoballoon after medical therapy
Cryoballoon ablation
|
|
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Experimental: Cryoballoon as first-line therapy
Cryoballoon ablation
|
|
|
Active Comparator: Cryoballoon after failed drug therapy
Cryoballoon ablation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 months from the procedure
|
|
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 months from the procedure
|
|
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
|
6 months from the procedure
|
|
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
|
9 months from the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
May 1, 2013
First Submitted That Met QC Criteria
August 7, 2013
First Posted (Estimate)
August 9, 2013
Study Record Updates
Last Update Posted (Estimate)
August 9, 2013
Last Update Submitted That Met QC Criteria
August 7, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3196568
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.