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').
Atrial flutter and atrial fibrillation are believed to share the same initiating triggers in the form of pulmonary vein ectopy. Cavo-tricuspid isthmus-dependent atrial flutter almost always results from short bursts of antecedent atrial fibrillation. Radiofrequency (RF) ablation of the cavo-tricuspid isthmus (CTI) is the current accepted first-line treatment for atrial flutter, although post-ablation atrial fibrillation commonly occurs, even in the absence of pre-existing atrial fibrillation. Cryoballoon Pulmonary Vein Isolation (PVI) has become an established treatment for atrial fibrillation. In patients with both atrial flutter and fibrillation, PVI alone has been shown to control both types of atrial arrhythmia, with no benefit derived from supplemental RF CTI ablation. This study aims to demonstrate that standalone cryoballoon PVI for typical atrial flutter without RF CTI ablation will lead to a significant difference in preventing recurrence of atrial arrhythmia compared to radiofrequency ablation of the CTI, and should be offered as first-line therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
113
Delivery of radiofrequency energy to the cavotricuspid isthmus (region of right atrial tissue between the tricuspid annulus and the inferior vena cava) until bidirectional block is achieved
Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation
University Hospital Basel
Basel, Switzerland
University Hospital Inselspital Bern
Bern, Switzerland
Royal Papworth Hospital NHS Foundation Trust
Papworth Everard, Cambridge, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
Manchester University NHS Foundation Trust, Wythenshawe Hospital
Manchester, United Kingdom
South Tees Hospitals NHS Foundation Trust, James Cook University Hospital
Middlesbrough, United Kingdom
The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
Newcastle upon Tyne, United Kingdom
Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital
Oxford, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
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
'Sustained' is defined as lasting \>30 seconds. 'Symptomatic' is defined as acute onset awareness of palpitations, breathlessness, dizziness, fatigue or chest pain associated with patient activation of the loop recorder.
Time frame: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Time to first symptomatic or asymptomatic Atrial Fibrillation lasting ≥2 min
How long it takes until first occurrence of atrial fibrillation (associated with symptoms or no symptoms) lasting 2 or more minutes after blanking period. Two minutes is the minimum duration detectable by the loop recorder
Time frame: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Total Burden of Atrial fibrillation over 12 months
The total occurrence of atrial fibrillation recorded by the loop recorder (symptomatic or asymptomatic) during the follow-up period
Time frame: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Time to first symptomatic or asymptomatic atrial flutter/atrial tachycardia
Occurrence of atrial flutter/atrial tachycardia with/without symptoms following the blanking period
Time frame: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Incidence of any significant arrhythmia
Incidence of any arrhythmia requiring medical visit to primary or secondary care, or hospitalisation, or leading to death
Time frame: After first ablation procedure, through study completion, an average of 12 months
Total burden of abnormal heart rhythm measured by the implantable loop recorder
Total arrhythmic burden up to end of follow up or up to time of intervention (either cardioversion or ablation), whichever comes first.
Time frame: After first ablation procedure through study completion or time of intervention, whichever comes first, assessed up to 12 months
Incidence of repeat electrophysiological interventional procedure (repeat catheter ablation, or DCCV) over the follow-up period.
Occurrence of repeat ablations/cardioversion
Time frame: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Incidence of procedural complications
Composite of cardiac tamponade requiring drainage, persistent phrenic nerve palsy lasting \>24 hours, serious vascular complications requiring intervention or delaying discharge, stroke/transient ischaemic attack, requirement for a permanent pacemaker, atrio-esophageal fistula, or death
Time frame: During and after ablation procedure, through study completion, an average of 12 months
Incidence of all-cause hospitalisations
Any hospital admission post-ablation
Time frame: After first ablation procedure, through study completion, an average of 12 months
Quality of Life questionnaire
Quality of life as assessed by the standard EuroQol Group's 5-dimensional questionnaire. This comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the visual analogue scale. The single digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state.
Time frame: At baseline and at 12 months
Procedural duration
Duration of ablation measured in minutes for either treatment
Time frame: Only during the first ablation procedure
Total Fluoroscopy times
The total time in minutes during which patient will be exposed to radiation under each of the two treatment techniques
Time frame: Only during the first ablation procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.