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

  • Turkey
      • Ankara, Turkey, 06100
        • Yuksek Ihtisas Heart-Education and Research Hospital

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
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

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

Yuksek Ihtisas Hospital

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.

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