Cryoballoon Ablation as First Line Treatment of Atrial Flutter

NCT ID: NCT03401099

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-17
• Study Completion Date: 2023-11-01

Brief 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').

Detailed Description

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.

Conditions

Atrial Flutter Typical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Radiofrequency ablation of CTI

Radiofrequency ablation of CTI (cavo-tricuspid isthmus), which is the 'conventional' treatment of atrial flutter

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation of CTI

Intervention Type: 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

Cryoballoon PVI

Cryoballoon PVI (Pulmonary Vein Isolation), which is the 'novel treatment'

Group Type: ACTIVE_COMPARATOR

Cryoballoon PVI

Intervention Type: PROCEDURE

Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation

Interventions

Radiofrequency ablation of CTI

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

Intervention Type: PROCEDURE

Cryoballoon PVI

Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation

Intervention Type: PROCEDURE

Other Intervention Names

CTI ablation; Cryoablation Pulmonary Vein Isolation

Eligibility Criteria

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 dysfunction (eGFR<30 ml/min)
• 16. Pregnancy
• 17. Severe valvular heart disease of any kind as assessed by the investigator
• 18. Previous valve replacement surgery or other prosthetic heart valve

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic International Trading Sarl

INDUSTRY

Sponsor Role: collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dhiraj Gupta, MBBS MD FRCP

Role: STUDY_CHAIR

Liverpool Heart and Chest Hospital

Locations

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

Countries

Switzerland; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 14610012 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25638698 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28335638 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36396438 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32385774 (View on PubMed)

Other Identifiers

1153

Identifier Type: -

Identifier Source: org_study_id