Cryoballoon Ablation as First Line Treatment of Atrial Flutter (NCT03401099) | Clinical Trial Compass
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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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