CompletedNot Applicable

Cryoballoon Ablation as First Line Treatment of Atrial Flutter

Switzerland, United Kingdom113 participantsStarted 2018-08-17

Plain-language summary

Current guidelines recommend radiofrequency catheter ablation of the cavotricuspid isthmus as treatment for symptomatic/drug-refractory atrial flutter, in spite of the fact that recurrences of flutter and incidence of post-ablation atrial fibrillation are common. In this study, the investigators assess the hypothesis that the use of cryoballoon Pulmonary Vein Isolation ('novel' treatment) to achieve the electrical disconnection between the pulmonary veins and the heart will lead to higher rates of freedom from abnormal heart rhythms (atrial flutter, atrial fibrillation, or atrial tachycardia) and more improved quality of life than treatment using heat energy (radiofrequency ablation) directed at the cavotricuspid isthmus ('conventional treatment').

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. Age 18-80 years * 2\. Patients referred for catheter ablation for typical atrial flutter. The atrial flutter may be either persistent or paroxysmal, with at least one episode having been documented on 12-lead ECG. In the view of the treating physician, the ECG morphology should be compatible with a CTI-dependent circuit, either counterclockwise or clockwise. Exclusion Criteria: * 1\. Any evidence of previously documented atrial fibrillation * 2\. Previous cavo-tricuspid isthmus ablation or atrial fibrillation ablation * 3\. Atrial flutter documented solely on Ambulatory monitoring * 4\. Atrial flutter morphology on ECG suggestive of a left atrial flutter * 5\. History of atrial flutter with 1:1 atrioventricular conduction and haemodynamic compromise * 6\. Indwelling atrial-septal defect occluder device, or any anatomical reason that precludes left atrial access * 7\. Left atrial diameter (PLAX M-mode) \>5.5 cm * 8\. Severe left ventricular dysfunction (LV ejection fraction \< 30% on Echocardiography) * 9\. Recent stroke/transient ischaemic attack within 3 months * 10\. Inability or unwillingness to take oral anticoagulant treatment * 11\. Morbid obesity (Body Mass Index ≥40) * 12\. Extreme frailty (A score of 7,8 or worse on the Clinical Frailty Scale) * 13\. Implanted metal prosthetic valve(s) in mitral position * 14\. Indwelling cardiac resynchronisation therapy device, pacemaker or implantable cardioverter defibrillator * 15\. Advanced Renal dy…

What they're measuring

Time to first recurrence of sustained, symptomatic supraventricular arrhythmia (Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) following a blanking period of 4 weeks after a single ablation procedure

Timeframe: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up

Trial details

NCT IDNCT03401099

SponsorLiverpool Heart and Chest Hospital NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Atrial Flutter Typical trials