Cryoballoon Ablation as First Line Treatment of Atrial Flutter

• Register: ClinicalTrials.gov
• Last refreshed on: 20 November 2023
• Main ID: NCT03401099
• Date of registration: 14/12/2017
• Prospective Registration: Yes
• Primary sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Public title: Cryoballoon Ablation as First Line Treatment of Atrial Flutter CRAFT
• Scientific title: Cryoballoon Pulmonary Vein Isolation as First Line Treatment for Typical Atrial Flutter
• Date of first enrolment: August 17, 2018
• Target sample size: 113
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03401099
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Switzerland, United Kingdom

Contacts

• Name: Dhiraj Gupta, MBBS MD FRCP
• Affiliation: Liverpool Heart and Chest Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Flutter Typical

Intervention(s)

Procedure: Cryoballoon PVI

Procedure: Radiofrequency ablation of CTI

Primary Outcome(s)

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 [Time Frame: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up]

Secondary Outcome(s)

Incidence of any significant arrhythmia [Time Frame: After first ablation procedure, through study completion, an average of 12 months]

Incidence of procedural complications [Time Frame: During and after ablation procedure, through study completion, an average of 12 months]

Incidence of repeat electrophysiological interventional procedure (repeat catheter ablation, or DCCV) over the follow-up period. [Time Frame: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up]

Procedural duration [Time Frame: Only during the first ablation procedure]

Incidence of all-cause hospitalisations [Time Frame: After first ablation procedure, through study completion, an average of 12 months]

Quality of Life questionnaire [Time Frame: At baseline and at 12 months]

Total Burden of Atrial fibrillation over 12 months [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 [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 [Time Frame: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up]

Total Fluoroscopy times [Time Frame: Only during the first ablation procedure]

Total burden of abnormal heart rhythm measured by the implantable loop recorder [Time Frame: After first ablation procedure through study completion or time of intervention, whichever comes first, assessed up to 12 months]

Secondary ID(s)

1153

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medtronic International Trading Sarl