Cryoballoon Ablation as First Line Treatment of Atrial Flutter

Atrial Flutter Typical Clinical Trial

— CRAFT  

Official title:

Cryoballoon Pulmonary Vein Isolation as First Line Treatment for Typical Atrial Flutter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401099
• Other study ID #: 1153
• Status: Completed
• Phase: N/A
• Start date: August 17, 2018
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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').

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: November 1, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter
• Atrial Flutter Typical

Intervention

Procedure:
• 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
• Cryoballoon PVI
Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Inselspital Bern	Bern
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	Royal Papworth Hospital NHS Foundation Trust	Papworth Everard	Cambridge
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust	Medtronic International Trading Sarl

Countries where clinical trial is conducted

Switzerland,  United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of all-cause hospitalisations	Any hospital admission post-ablation	After first ablation procedure, through study completion, an average of 12 months
Secondary	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
Secondary	Procedural duration	Duration of ablation measured in minutes for either treatment	Only during the first ablation procedure
Secondary	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