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

Primary Purpose

Atrial Flutter Typical

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Radiofrequency ablation of CTI
Cryoballoon PVI
Sponsored by
Liverpool Heart and Chest Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter Typical focused on measuring Radiofrequency ablation, Cavo-tricuspid isthmus, Pulmonary Vein Isolation, Cryoballoon ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel
  • University Hospital Inselspital Bern
  • Royal Papworth Hospital NHS Foundation Trust
  • Leeds Teaching Hospitals NHS Trust
  • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • Manchester University NHS Foundation Trust, Wythenshawe Hospital
  • South Tees Hospitals NHS Foundation Trust, James Cook University Hospital
  • The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
  • Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital
  • University Hospitals Plymouth NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Radiofrequency ablation of CTI

Cryoballoon PVI

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Time to first symptomatic or asymptomatic atrial flutter/atrial tachycardia
Occurrence of atrial flutter/atrial tachycardia with/without symptoms following the blanking period
Incidence of any significant arrhythmia
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
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.
Occurrence of repeat ablations/cardioversion
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
Incidence of all-cause hospitalisations
Any hospital admission post-ablation
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.
Procedural duration
Duration of ablation measured in minutes for either treatment
Total Fluoroscopy times
The total time in minutes during which patient will be exposed to radiation under each of the two treatment techniques

Full Information

First Posted
December 14, 2017
Last Updated
October 3, 2023
Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators
Medtronic International Trading Sarl
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1. Study Identification

Unique Protocol Identification Number
NCT03401099
Brief Title
Cryoballoon Ablation as First Line Treatment of Atrial Flutter
Acronym
CRAFT
Official Title
Cryoballoon Pulmonary Vein Isolation as First Line Treatment for Typical Atrial Flutter
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 17, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators
Medtronic International Trading Sarl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter Typical
Keywords
Radiofrequency ablation, Cavo-tricuspid isthmus, Pulmonary Vein Isolation, Cryoballoon ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomised 1:1 into two groups to receive either of the two treatments.
Masking
Outcomes Assessor
Masking Description
Blinded outcome assessment
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency ablation of CTI
Arm Type
Active Comparator
Arm Description
Radiofrequency ablation of CTI (cavo-tricuspid isthmus), which is the 'conventional' treatment of atrial flutter
Arm Title
Cryoballoon PVI
Arm Type
Active Comparator
Arm Description
Cryoballoon PVI (Pulmonary Vein Isolation), which is the 'novel treatment'
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation of CTI
Other Intervention Name(s)
CTI ablation
Intervention Description
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
Intervention Name(s)
Cryoballoon PVI
Other Intervention Name(s)
Cryoablation Pulmonary Vein Isolation
Intervention Description
Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation
Primary Outcome Measure Information:
Title
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
Description
'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.
Time Frame
After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Secondary Outcome Measure Information:
Title
Time to first symptomatic or asymptomatic Atrial Fibrillation lasting ≥2 min
Description
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
Time Frame
After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Title
Total Burden of Atrial fibrillation over 12 months
Description
The total occurrence of atrial fibrillation recorded by the loop recorder (symptomatic or asymptomatic) during the follow-up period
Time Frame
After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Title
Time to first symptomatic or asymptomatic atrial flutter/atrial tachycardia
Description
Occurrence of atrial flutter/atrial tachycardia with/without symptoms following the blanking period
Time Frame
After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Title
Incidence of any significant arrhythmia
Description
Incidence of any arrhythmia requiring medical visit to primary or secondary care, or hospitalisation, or leading to death
Time Frame
After first ablation procedure, through study completion, an average of 12 months
Title
Total burden of abnormal heart rhythm measured by the implantable loop recorder
Description
Total arrhythmic burden up to end of follow up or up to time of intervention (either cardioversion or ablation), whichever comes first.
Time Frame
After first ablation procedure through study completion or time of intervention, whichever comes first, assessed up to 12 months
Title
Incidence of repeat electrophysiological interventional procedure (repeat catheter ablation, or DCCV) over the follow-up period.
Description
Occurrence of repeat ablations/cardioversion
Time Frame
After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Title
Incidence of procedural complications
Description
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
Time Frame
During and after ablation procedure, through study completion, an average of 12 months
Title
Incidence of all-cause hospitalisations
Description
Any hospital admission post-ablation
Time Frame
After first ablation procedure, through study completion, an average of 12 months
Title
Quality of Life questionnaire
Description
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.
Time Frame
At baseline and at 12 months
Title
Procedural duration
Description
Duration of ablation measured in minutes for either treatment
Time Frame
Only during the first ablation procedure
Title
Total Fluoroscopy times
Description
The total time in minutes during which patient will be exposed to radiation under each of the two treatment techniques
Time Frame
Only during the first ablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhiraj Gupta, MBBS MD FRCP
Organizational Affiliation
Liverpool Heart and Chest Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Facility Name
University Hospital Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
Royal Papworth Hospital NHS Foundation Trust
City
Papworth Everard
State/Province
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust, Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
South Tees Hospitals NHS Foundation Trust, James Cook University Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
14610012
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.
Results Reference
background
PubMed Identifier
25638698
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.
Results Reference
background
PubMed Identifier
28335638
Citation
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.
Results Reference
background
PubMed Identifier
36396438
Citation
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.
Results Reference
derived
PubMed Identifier
32385774
Citation
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.
Results Reference
derived

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Cryoballoon Ablation as First Line Treatment of Atrial Flutter

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