Cryoablation in Patients With Atrial Flutter

Phase 2

• Conditions: Atrial Flutter

• Registration Number: NCT01563848
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

The investigators hypothesized that revealing the incidence of AF following RFA of the CTI and cryoablation PVI reduces incidence of AF following RFA of the CTI.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Primary Completion: 2015-06
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age ≥ 18 years
• ECG documented paroxysmal or persistent AFL
• No prior documented history of AF
• Patient undergoing RFA of the CTI for AFL.
• No indication (other than AFL) for continued anticoagulation with warfarin.
• No existing implantable cardiac device (pacemaker, defibrillator, cardiac resynchronization therapy device)
• Availability of an analog phone line.

Exclusion Criteria

• a history of atrial fibrillation
• Previous AF ablation procedure
• Congestive heart failure
• Left Ventricle ejection fraction less than 35%
• Unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of AF burden	3 years

Secondary Outcome Measures

Name	Time	Method
thromboembolic events	3 years
hospitalizations	3 years
procedural complications	3 years
drug adverse effects	3 years
number of crossovers	3 years
All-cause death	3 years

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation