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

Paroxysmal Atrial Fibrillation Clinical Trial

— C-frost  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920295
• Other study ID #: 3196568
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: August 7, 2013
• Start date: January 2011
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Yuksek Ihtisas Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• paroxysmal atrial fibrillation, symptomatic

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Cryoballoon ablation

Locations

Country	Name	City	State
Turkey	Yuksek Ihtisas Heart-Education and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Yuksek Ihtisas Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months from the procedure	No
Primary	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	3 months from the procedure	No
Primary	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	6 months from the procedure	No
Primary	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	9 months from the procedure	No