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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cryoballoon ablation
Sponsored by
Yuksek Ihtisas Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • paroxysmal atrial fibrillation, symptomatic

Exclusion Criteria:

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

Sites / Locations

  • Yuksek Ihtisas Heart-Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Cryoballoon ablation

Cryoballoon after medical therapy

Cryoballoon as first-line therapy

Cryoballoon after failed drug therapy

Arm Description

Cryoballoon ablation

Cryoballoon ablation

Cryoballoon ablation

Cryoballoon ablation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 1, 2013
Last Updated
August 7, 2013
Sponsor
Yuksek Ihtisas Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01920295
Brief Title
Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy
Acronym
C-frost
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuksek Ihtisas Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryoballoon ablation
Arm Type
Experimental
Arm Description
Cryoballoon ablation
Arm Title
Cryoballoon after medical therapy
Arm Type
Active Comparator
Arm Description
Cryoballoon ablation
Arm Title
Cryoballoon as first-line therapy
Arm Type
Experimental
Arm Description
Cryoballoon ablation
Arm Title
Cryoballoon after failed drug therapy
Arm Type
Active Comparator
Arm Description
Cryoballoon ablation
Intervention Type
Device
Intervention Name(s)
Cryoballoon ablation
Primary Outcome Measure Information:
Title
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
Description
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
Time Frame
12 months from the procedure
Title
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
Description
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
Time Frame
3 months from the procedure
Title
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
Description
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
Time Frame
6 months from the procedure
Title
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
Description
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
Time Frame
9 months from the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: paroxysmal atrial fibrillation, symptomatic Exclusion Criteria: atrial fibrillation other than PAF, asymptomatic, previous AF ablation
Facility Information:
Facility Name
Yuksek Ihtisas Heart-Education and Research Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

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

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