Atrial Flutter TypicalCRAFTNCT03401099
Cryoballoon Ablation as First Line Treatment of Atrial Flutter
A study testing Radiofrequency ablation of CTI and Cryoballoon PVI in people with Atrial Flutter Typical, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 10 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Flutter Typical
- What is being tested?
- Radiofrequency ablation of CTI and Cryoballoon PVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 17 Aug 2018to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United Kingdom8 sites
Leeds Teaching Hospitals NHS Trust
Leeds
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L14 3PE
Manchester University NHS Foundation Trust, Wythenshawe Hospital
Manchester, M23 9LT
South Tees Hospitals NHS Foundation Trust, James Cook University Hospital
Middlesbrough, TS4 3BW
The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital
Oxford, OX3 9DU
Royal Papworth Hospital NHS Foundation Trust
Papworth Everard, Cambridge, CB23 3RE
University Hospitals Plymouth NHS Trust
Plymouth
Switzerland2 sites
University Hospital Basel
Basel
University Hospital Inselspital Bern
Bern
About this study
Official title: Cryoballoon Pulmonary Vein Isolation as First Line Treatment for Typical Atrial Flutter
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').
Read the 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.
- Conditions
- Atrial Flutter Typical
- Being tested
- Radiofrequency ablation of CTI, Cryoballoon PVI
- Keywords
- Radiofrequency ablation, Cavo-tricuspid isthmus, Pulmonary Vein Isolation, Cryoballoon ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation of CTIProcedure or surgery
Also called CTI ablation
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 PVIProcedure or surgery
Also called Cryoablation Pulmonary Vein Isolation
Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation of CTI | Active comparator | Radiofrequency ablation of CTI (cavo-tricuspid isthmus), which is the 'conventional' treatment of atrial flutter Receives: Procedure: Radiofrequency ablation of CTI |
| Cryoballoon PVI | Active comparator | Cryoballoon PVI (Pulmonary Vein Isolation), which is the 'novel treatment' Receives: Procedure: Cryoballoon PVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
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
Measured: 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
Occurrence of atrial flutter/atrial tachycardia with/without symptoms following the blanking period
Measured: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Incidence of any significant arrhythmia
Incidence of any arrhythmia requiring medical visit to primary or secondary care, or hospitalisation, or leading to death
Measured: After first ablation procedure, through study completion, an average of 12 months
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.
Measured: After first ablation procedure through study completion or time of intervention, whichever comes first, assessed up to 12 months
Incidence of repeat electrophysiological interventional procedure (repeat catheter ablation, or DCCV) over the follow-up period.
Occurrence of repeat ablations/cardioversion
Measured: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
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
Measured: During and after ablation procedure, through study completion, an average of 12 months
Incidence of all-cause hospitalisations
Any hospital admission post-ablation
Measured: After first ablation procedure, through study completion, an average of 12 months
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.
Measured: At baseline and at 12 months
Procedural duration
Duration of ablation measured in minutes for either treatment
Measured: Only during the first ablation procedure
Total Fluoroscopy times
The total time in minutes during which patient will be exposed to radiation under each of the two treatment techniques
Measured: Only during the first ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start17 Aug 2018
- Primary completion1 Dec 2021
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial Flutter TypicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised 1:1 into two groups to receive either of the two treatments.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic International Trading Sarl
- Responsible party
- Sponsor
- Investigators
- Dhiraj Gupta, MBBS MD FRCP, Study chair, Liverpool Heart and Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401099
- Sponsor's protocol ID
- 1153
- Acronym
- CRAFT
- Status last verified
- Nov 2023
- First submitted
- 14 Dec 2017
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 14610012Schneider 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.
PubMed 25638698De 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.
PubMed 28335638Gupta 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.
PubMed 36396438Ding 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.
PubMed 32385774
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon Pulmonary Vein Isolation as First Line Treatment for Typical Atrial Flutter
- ClinicalTrials.gov ID
- NCT03401099
- Acronym / sponsor ID
- CRAFT / 1153
- Conditions
- Atrial Flutter Typical
- Keywords
- Radiofrequency ablation, Cavo-tricuspid isthmus, Pulmonary Vein Isolation, Cryoballoon ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medtronic International Trading Sarl
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomised 1:1 into two groups to receive either of the two treatments.
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation of CTI | Active comparator | Procedure: Radiofrequency ablation of CTIRadiofrequency ablation of CTI (cavo-tricuspid isthmus), which is the 'conventional' treatment of atrial flutter |
| Cryoballoon PVI | Active comparator | Procedure: Cryoballoon PVICryoballoon PVI (Pulmonary Vein Isolation), which is the 'novel treatment' |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation of CTIAlso: CTI ablationDelivery 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 | Procedure or surgery | Radiofrequency ablation of CTI |
| Cryoballoon PVIAlso: Cryoablation Pulmonary Vein IsolationCryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation | Procedure or surgery | Cryoballoon PVI |
Primary outcome
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.
11 secondary outcomes
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
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 flutter/atrial tachycardia
Time frame: After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up
Incidence of any significant arrhythmia
Time frame: After first ablation procedure, through study completion, an average of 12 months
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
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
Incidence of procedural complications
Time frame: During and after ablation procedure, through study completion, an average of 12 months
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
Procedural duration
Time frame: Only during the first ablation procedure
Total Fluoroscopy times
Time frame: Only during the first ablation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 14610012Wazni 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.
- Background: PubMed 25638698Schneider 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.
- Background: PubMed 28335638De 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.
- Derived from this study: PubMed 36396438Gupta 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.
- Derived from this study: PubMed 32385774Ding 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhiraj Gupta, MBBS MD FRCP study chair
Liverpool Heart and Chest Hospital
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation of CTI and Cryoballoon PVI in people with Atrial Flutter Typical, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03401099, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.