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| Name | Class |
|---|---|
| Medtronic International Trading Sarl | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablation of CTI | Active Comparator | Radiofrequency ablation of CTI (cavo-tricuspid isthmus), which is the 'conventional' treatment of atrial flutter |
|
| Cryoballoon PVI | Active Comparator | Cryoballoon PVI (Pulmonary Vein Isolation), which is the 'novel treatment' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation of CTI | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhiraj Gupta, MBBS MD FRCP | Liverpool Heart and Chest Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Switzerland | ||||
| University Hospital Inselspital Bern |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14610012 | Background | Wazni O, Marrouche NF, Martin DO, Gillinov AM, Saliba W, Saad E, Klein A, Bhargava M, Bash D, Schweikert R, Erciyes D, Abdul-Karim A, Brachman J, Gunther J, Pisano E, Potenza D, Fanelli R, Natale A. Randomized study comparing combined pulmonary vein-left atrial junction disconnection and cavotricuspid isthmus ablation versus pulmonary vein-left atrial junction disconnection alone in patients presenting with typical atrial flutter and atrial fibrillation. Circulation. 2003 Nov 18;108(20):2479-83. doi: 10.1161/01.CIR.0000101684.88679.AB. Epub 2003 Nov 10. | |
| 25638698 |
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There is no plan to share Individual Participant Data with other researchers.
Supporting information that will be shared are only:
Study Protocol, Statistical Analysis Plan (SAP), and Clinical Study Report (CSR)
Data will be available after about 6 months for about 5 years.
Criteria for which Individual Participant Data and any additional supporting information will be shared, including with whom, for what types of analyses, and by what mechanism:
These will be shared with research co-workers, for results, statistical analysis and conclusions. Communication of anonymized data will be done via secure mails and emails.
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Participants will be randomised 1:1 into two groups to receive either of the two treatments.
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Blinded outcome assessment
|
| Cryoballoon PVI | Procedure | Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation |
|
|
| 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 | 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 | 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 | 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. | 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 | 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 | During and after ablation procedure, through study completion, an average of 12 months |
| Incidence of all-cause hospitalisations | Any hospital admission post-ablation | 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. | At baseline and at 12 months |
| Procedural duration | Duration of ablation measured in minutes for either treatment | 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 | Only during the first ablation procedure |
| Bern |
| Switzerland |
| Royal Papworth Hospital NHS Foundation Trust | Papworth Everard | Cambridge | CB23 3RE | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | L14 3PE | United Kingdom |
| Manchester University NHS Foundation Trust, Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |
| South Tees Hospitals NHS Foundation Trust, James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| University Hospitals Plymouth NHS Trust | Plymouth | United Kingdom |
| Background |
| Schneider R, Lauschke J, Tischer T, Schneider C, Voss W, Moehlenkamp F, Glass A, Diedrich D, Bansch D. Pulmonary vein triggers play an important role in the initiation of atrial flutter: Initial results from the prospective randomized Atrial Fibrillation Ablation in Atrial Flutter (Triple A) trial. Heart Rhythm. 2015 May;12(5):865-71. doi: 10.1016/j.hrthm.2015.01.040. Epub 2015 Jan 28. |
| 28335638 | Background | De Bortoli A, Shi LB, Ohm OJ, Hoff PI, Schuster P, Solheim E, Chen J. Incidence and clinical predictors of subsequent atrial fibrillation requiring additional ablation after cavotricuspid isthmus ablation for typical atrial flutter. Scand Cardiovasc J. 2017 Jun;51(3):123-128. doi: 10.1080/14017431.2017.1304570. Epub 2017 Mar 23. |
| 36396438 | Derived | Gupta D, Ding WY, Calvert P, Williams E, Das M, Tovmassian L, Tayebjee MH, Haywood G, Martin CA, Rajappan K, Bates MGD, Temple IP, Reichlin T, Chen Z, Balasubramaniam RN, Ronayne C, Clarkson N, Morgan M, Barton J, Kemp I, Mahida S, Sticherling C. Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter. Heart. 2023 Feb 14;109(5):364-371. doi: 10.1136/heartjnl-2022-321729. |
| 32385774 | Derived | Ding WY, Williams E, Das M, Tovmassian L, Tayebjee M, Haywood G, Martin C, Rajappan K, Bates M, Temple IP, Reichlin T, Chen Z, Balasubramaniam R, Ronayne C, Clarkson N, Mahida S, Sticherling C, Gupta D. Cryoballoon pulmonary vein isolation as first line treatment for typical atrial flutter (CRAFT): study protocol for a randomised controlled trial. J Interv Card Electrophysiol. 2021 Apr;60(3):427-432. doi: 10.1007/s10840-020-00746-6. Epub 2020 May 8. |