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Cryoballoon Ablation as First Line Treatment of Atrial Flutter (CRAFT)

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ClinicalTrials.gov Identifier: NCT03401099
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
Medtronic International Trading Sarl
Information provided by (Responsible Party):
Liverpool Heart and Chest Hospital NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE December 14, 2017
First Posted Date  ICMJE January 17, 2018
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE August 17, 2018
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
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 ]
'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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • 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 ]
    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
  • 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 ]
    The total occurrence of atrial fibrillation recorded by the loop recorder (symptomatic or asymptomatic) during the follow-up period
  • 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 ]
    Occurrence of atrial flutter/atrial tachycardia with/without symptoms following the blanking period
  • Incidence of any significant arrhythmia [ Time Frame: After first ablation procedure, through study completion, an average of 12 months ]
    Incidence of any arrhythmia requiring medical visit to primary or secondary care, or hospitalisation, or leading to death
  • 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 ]
    Total arrhythmic burden up to end of follow up or up to time of intervention (either cardioversion or ablation), whichever comes first.
  • 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 ]
    Occurrence of repeat ablations/cardioversion
  • Incidence of procedural complications [ Time Frame: During and after ablation procedure, through study completion, an average of 12 months ]
    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
  • Incidence of all-cause hospitalisations [ Time Frame: After first ablation procedure, through study completion, an average of 12 months ]
    Any hospital admission post-ablation
  • Quality of Life questionnaire [ Time Frame: At baseline and at 12 months ]
    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.
  • Procedural duration [ Time Frame: Only during the first ablation procedure ]
    Duration of ablation measured in minutes for either treatment
  • Total Fluoroscopy times [ Time Frame: Only during the first ablation procedure ]
    The total time in minutes during which patient will be exposed to radiation under each of the two treatment techniques
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
  • 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 ]
    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
  • 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 ]
    The total occurrence of atrial fibrillation recorded by the loop recorder (symptomatic or asymptomatic) during the follow-up period
  • 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 ]
    Occurrence of atrial flutter/atrial tachycardia with/without symptoms following the blanking period
  • Incidence of any significant arrhythmia [ Time Frame: After first ablation procedure, through study completion, an average of 12 months ]
    Incidence of any arrhythmia requiring medical visit to primary or secondary care, or hospitalisation, or leading to death
  • 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 ]
    Total arrhythmic burden up to end of follow up or up to time of intervention (either cardioversion or ablation), whichever comes first.
  • 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 ]
    Occurrence of repeat ablations/cardioversion
  • Incidence of procedural complications [ Time Frame: During and after ablation procedure, through study completion, an average of 12 months ]
    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
  • Incidence of all-cause hospitalisations [ Time Frame: After first ablation procedure, through study completion, an average of 12 months ]
    Any hospital admission post-ablation
  • Quality of Life [ Time Frame: At 6 months and at 12 months ]
    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.
  • Procedural duration [ Time Frame: Only during the first ablation procedure ]
    Duration of ablation measured in minutes for either treatment
  • Total Fluoroscopy times [ Time Frame: Only during the first ablation procedure ]
    The total time in minutes during which patient will be exposed to radiation under each of the two treatment techniques
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryoballoon Ablation as First Line Treatment of Atrial Flutter
Official Title  ICMJE Cryoballoon Pulmonary Vein Isolation as First Line Treatment for Typical Atrial Flutter
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 asses 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomised 1:1 into two groups to receive either of the two treatments.
Masking: Single (Outcomes Assessor)
Masking Description:
Blinded outcome assessment
Primary Purpose: Treatment
Condition  ICMJE Atrial Flutter Typical
Intervention  ICMJE
  • 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
    Other Name: CTI ablation
  • Procedure: Cryoballoon PVI
    Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation
    Other Name: Cryoablation Pulmonary Vein Isolation
Study Arms  ICMJE
  • Active Comparator: Radiofrequency ablation of CTI
    Radiofrequency ablation of CTI (cavo-tricuspid isthmus), which is the 'conventional' treatment of atrial flutter
    Intervention: Procedure: Radiofrequency ablation of CTI
  • Active Comparator: Cryoballoon PVI
    Cryoballoon PVI (Pulmonary Vein Isolation), which is the 'novel treatment'
    Intervention: Procedure: Cryoballoon PVI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 9, 2018)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2021
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emmanuel A Williams, MBChB MRCP 07902785128 Emmanuel.Williams@lhch.nhs.uk
Contact: Dhiraj Gupta, MBBS MD FRCP 01516001793 Dhiraj.Gupta@lhch.nhs.uk
Listed Location Countries  ICMJE Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03401099
Other Study ID Numbers  ICMJE 1153
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description:

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.

Responsible Party Liverpool Heart and Chest Hospital NHS Foundation Trust
Study Sponsor  ICMJE Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators  ICMJE Medtronic International Trading Sarl
Investigators  ICMJE
Study Chair: Dhiraj Gupta, MBBS MD FRCP Liverpool Heart and Chest Hospital
PRS Account Liverpool Heart and Chest Hospital NHS Foundation Trust
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP