Cryoablation of atrial flutter

Completed

• Conditions: Atrial flutter; Circulatory System; Atrial fibrillation and flutter

• Registration Number: ISRCTN46168176
• Lead Sponsor: Karolinska University Hospital (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Consecutive patients referred to our institution for ablation therapy of ECG-documented typical CTI-dependent AFL
2. Patients above the age of 18 with symptomatic CTI-dependent AFL documented on a 12-lead ECG with typical ECG appearance of negative saw tooth waves in the inferior limb leads and positive deflections in V1 or positive saw tooth waves in the inferior limb leads and negative deflections in V1
3. Patients with a history of atrial fibrillation included if they had predominant atrial flutter under chronic treatment with class I or III antiarrhythmic agents

Exclusion Criteria

1. Prior ablation for AFL
2. Atrial flutter related to recently undergone surgery, hyperthyroidism or other severe disease
3. Inability to adhere to the study protocol
4. Pregnancy
5. Predominant atrial fibrillation
6. Contraindication to warfarin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical success defined as the freedom from atrial flutter evaluated at the 6-month follow-up.

Secondary Outcome Measures

Name	Time	Method
1. Acute ablation success defined as bidirectional CTI-block safety assessed by the rate of periprocedural complications, procedure and fluoroscopy times and the level of pain experienced by the patient during the ablation procedure<br>2. To compare the utility of non-fluoroscopic mapping systems (Ensite NavX) with conventional mapping all patients were also randomized to either fluoroscopy only or Ensite NavX and fluoroscopy