NCT03401099

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').

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

August 17, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

3.3 years

First QC Date

December 14, 2017

Last Update Submit

November 10, 2023

Conditions

Atrial Flutter Typical

Keywords

Radiofrequency ablationCavo-tricuspid isthmusPulmonary Vein IsolationCryoballoon ablation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Time to first symptomatic or asymptomatic Atrial Fibrillation lasting ≥2 min

    After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up

  • Total Burden of Atrial fibrillation over 12 months

    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

    After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up

  • Incidence of any significant arrhythmia

    After first ablation procedure, through study completion, an average of 12 months

  • Total burden of abnormal heart rhythm measured by the implantable loop recorder

    After first ablation procedure through study completion or time of intervention, whichever comes first, assessed up to 12 months

  • +6 more secondary outcomes

Study Arms (2)

Radiofrequency ablation of CTI

ACTIVE COMPARATOR

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

Procedure: Radiofrequency ablation of CTI

Cryoballoon PVI

ACTIVE COMPARATOR

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

Procedure: Cryoballoon PVI

Interventions

Radiofrequency ablation of CTIPROCEDURE

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

Also known as: CTI ablation
Radiofrequency ablation of CTI
Cryoballoon PVIPROCEDURE

Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation

Also known as: Cryoablation Pulmonary Vein Isolation
Cryoballoon PVI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age 18-80 years
  • \. 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.

You may not qualify if:

  • \. Any evidence of previously documented atrial fibrillation
  • \. Previous cavo-tricuspid isthmus ablation or atrial fibrillation ablation
  • \. Atrial flutter documented solely on Ambulatory monitoring
  • \. Atrial flutter morphology on ECG suggestive of a left atrial flutter
  • \. History of atrial flutter with 1:1 atrioventricular conduction and haemodynamic compromise
  • \. Indwelling atrial-septal defect occluder device, or any anatomical reason that precludes left atrial access
  • \. Left atrial diameter (PLAX M-mode) \>5.5 cm
  • \. Severe left ventricular dysfunction (LV ejection fraction \< 30% on Echocardiography)
  • \. Recent stroke/transient ischaemic attack within 3 months
  • \. Inability or unwillingness to take oral anticoagulant treatment
  • \. Morbid obesity (Body Mass Index ≥40)
  • \. Extreme frailty (A score of 7,8 or worse on the Clinical Frailty Scale)
  • \. Implanted metal prosthetic valve(s) in mitral position
  • \. Indwelling cardiac resynchronisation therapy device, pacemaker or implantable cardioverter defibrillator
  • \. Advanced Renal dysfunction (eGFR\<30 ml/min)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Hospital Basel

Basel, Switzerland

Location

University Hospital Inselspital Bern

Bern, Switzerland

Location

Royal Papworth Hospital NHS Foundation Trust

Papworth Everard, Cambridge, CB23 3RE, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, L14 3PE, United Kingdom

Location

Manchester University NHS Foundation Trust, Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

South Tees Hospitals NHS Foundation Trust, James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 14610012BACKGROUND

  • 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.

    PMID: 25638698BACKGROUND

  • 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.

    PMID: 28335638BACKGROUND

  • 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.

    PMID: 36396438DERIVED

  • 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.

    PMID: 32385774DERIVED

Study Officials

  • Dhiraj Gupta, MBBS MD FRCP

    Liverpool Heart and Chest Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded outcome assessment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomised 1:1 into two groups to receive either of the two treatments.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2017

First Posted

January 17, 2018

Study Start

August 17, 2018

Primary Completion

December 1, 2021

Study Completion

November 1, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

GB(8)CH(2)