Cryoablation in Patients With Atrial Flutter (CIAFL)

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Atrial Flutter

Treatments: Procedure: Implantation of loop recorder; Procedure: Cryoballoon ablation; Procedure: Radiofrequency ablation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01563848

CAAF-712

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group 1 (RFA CTI+Reveal)

Active Comparator group

Description:

assessing the incidence of atrial fibrillation in patients with atrial flutter

Treatment:

Procedure: Implantation of loop recorder

Procedure: Radiofrequency ablation

Group 2 (RFA CTI+Cryo PVI+Reveal)

Active Comparator group

Description:

efficacy of cryoablation in patients with atrial flutter

Treatment:

Procedure: Implantation of loop recorder

Procedure: Radiofrequency ablation

Procedure: Cryoballoon ablation