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

November 10, 2023 updated by: Liverpool Heart and Chest Hospital NHS Foundation Trust

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').

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel
      • Bern, Switzerland
        • University Hospital Inselspital Bern
  • United Kingdom
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust
      • Liverpool, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • Manchester, United Kingdom, M23 9LT
        • Manchester University NHS Foundation Trust, Wythenshawe Hospital
      • Middlesbrough, United Kingdom, TS4 3BW
        • South Tees Hospitals NHS Foundation Trust, James Cook University Hospital
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital
      • Plymouth, United Kingdom
        • University Hospitals Plymouth NHS Trust
    • Cambridge
      • Papworth Everard, Cambridge, United Kingdom, CB23 3RE
        • Royal Papworth Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Radiofrequency ablation of CTI
Radiofrequency ablation of CTI (cavo-tricuspid isthmus), which is the 'conventional' treatment of atrial flutter
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 Names:
  • CTI ablation
Active Comparator: Cryoballoon PVI
Cryoballoon PVI (Pulmonary Vein Isolation), which is the 'novel treatment'
Procedure: Cryoballoon PVI
Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation
Other Names:
  • Cryoablation Pulmonary Vein Isolation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After 4 weeks of ablation treatment (blanking period) up to 12 months of follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
The total occurrence of atrial fibrillation recorded by the loop recorder (symptomatic or asymptomatic) during the follow-up period
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
Occurrence of atrial flutter/atrial tachycardia with/without symptoms following the blanking period
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
Incidence of any arrhythmia requiring medical visit to primary or secondary care, or hospitalisation, or leading to death
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
Total arrhythmic burden up to end of follow up or up to time of intervention (either cardioversion or ablation), whichever comes first.
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
Occurrence of repeat ablations/cardioversion
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
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
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
Any hospital admission post-ablation
After first ablation procedure, through study completion, an average of 12 months
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.
At baseline and at 12 months
Procedural duration
Time Frame: Only during the first ablation procedure
Duration of ablation measured in minutes for either treatment
Only during the first ablation procedure
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
Only during the first ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liverpool Heart and Chest Hospital NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic International Trading Sarl

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dhiraj Gupta, MBBS MD FRCP, Liverpool Heart and Chest Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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