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Cryoablation of atrial flutter

Cryothermal versus Radiofrequency Ablation as atrial Flutter Therapy: a randomized comparison

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46168176
Enrollment
150
Registered
2012-04-03
Start date
2007-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial flutter Circulatory System Atrial fibrillation and flutter

Interventions

Cryo group: Cryo was delivered with the use of a steerable 9F, 8-mm-tip catheter (Freezor MAX, CryoCath, Quebec, Canada), which was positioned on the TV annulus. Cryoablation was then performed using

Sponsors

Karolinska University Hospital (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Clinical success defined as the freedom from atrial flutter evaluated at the 6-month follow-up.

Secondary

MeasureTime frame
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 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

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026