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Typical Atrial FlutterFLUTTERNCT04434599

Fluoroscopic, Contact Force and Local Impedance With Ultra-high Density Mapping Guided Radiofrequency Ablation Comparison for cavoTricuspid Isthmus dependenT Atrial fluttER: the FLUTTER Study

A study testing Fluoroscopically guided ablation, Contact force guided ablation and Local impedance guide ablation in people with Typical Atrial Flutter, run by University of Manchester.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Catheter ablation is a first-line treatment for patients with cavotricuspid isthmus (CTI) dependent atrial flutter (AFL; also known as typical AFL), a common arrhythmia. This is done using radiofrequency (RF) catheters and single-procedure success is approximately 95%. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Typical Atrial Flutter
What is being tested?
Fluoroscopically guided ablation, Contact force guided ablation and Local impedance guide ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Oct 2022to 1 Jan 2024
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

  • Patients under the care of the NHS
  • Aged 18-80 years
  • Symptoms and 12-lead ECG suggestive of typical (cavotricuspid isthmus dependent) atrial flutter
  • Due to undergo first-time cavotricuspid isthmus ablation (including as part of a combined ablation if also having pulmonary vein isolation for atrial fibrillation) on clinical grounds

Who cannot join

  • Pre-procedure:
  • Inability to given informed consent / lack of mental capacity
  • Obesity (BMI >40)
  • Congenital heart disease or tricuspid valve abnormalities likely to prolong procedure time, including Ebstein anomaly, atrial septal defects, tricuspid valve repair or replacement, severe tricuspid valve regurgitation
  • Inability or unwillingness to receive oral anticoagulation with a vitamin K antagonist (VKA) or non-VKA oral anticoagulant (NOAC)
  • Previous cavotricuspid isthmus ablation procedure
Show all 12Show fewer
  • Known infiltrative cardiomyopathy
  • Pregnancy
  • Age < 18 or >80
  • Inability to speak adequate English/need for an interpreter for study consent process
  • Post procedure:
  • arrhythmia mechanism found not to be cavotricuspid isthmus dependent atrial flutter

About this study

Catheter ablation is a first-line treatment for patients with cavotricuspid isthmus (CTI) dependent atrial flutter (AFL; also known as typical AFL), a common arrhythmia. This is done using radiofrequency (RF) catheters and single-procedure success is approximately 95%. Ablation is often done using one of three methods:

  1. fluoroscopically, using X-rays to guide the operator to visualise catheter position within the heart. This method involves the most radiation exposure to patient and operator. Ablation is generally performed for a set time-period (eg. 30-60secs) to ensure each ablation lesion is successful.
  2. using a 3-dimensional mapping system which allows the catheters to be magnetically located and visualised on a monitor without X-rays, and using "contact force" (CF) sensing catheters. This requires minimal X-ray use, and by ensuring a minimum degree of force between catheter tip and the heart before applying RF for a set time-period (eg. 30 seconds), operators can be more confident of successful lesions.
  3. using an ultra-high density mapping system which uses magnetic tracking as above, but allows higher resolution visualisation of the cardiac electrical system with potential for improving procedure success; this has not yet been formally evaluated for AFL. Catheters using this method use "local impedance" (LI) instead of CF. This is a direct measure of heart tissue impedance with real-time changes during ablation. A minimum drop or plateau in the LI value during ablation allows confidence of lesion success, without the need to ablate for a pre-defined time-period. This could potentially reduce ablation time and subsequent complications, but has also not yet been formally compared to the above for this indication.

This prospective randomised study aims to compare these three standard of care procedures to determine if differences in ablation metrics, efficacy and safety exist.

Being tested
Fluoroscopically guided ablation, Contact force guided ablation, Local impedance guide ablation
Keywords
radiofrequency ablation, contact force, local impedance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluoroscopically guided ablationDevice

    Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by fluoroscopy

  • Contact force guided ablationDevice

    Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by contact force measurement and 3D electroanatomic mapping

  • Local impedance guide ablationDevice

    Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by local impedance measurement and ultra-high density 3D electroanatomic mapping

Study groups in NCT04434599
Study groupRoleWhat they receive
Fluoroscopically guided ablationActive comparatorThese patients will receive one catheter ablation of typical atrial flutter by fluoroscopically guided radiofrequency ablation catheters
Receives: Device: Fluoroscopically guided ablation
Contact force guided ablationActive comparatorThese patients will receive one catheter ablation of typical atrial flutter by contact force guided radiofrequency ablation catheters using the CARTO 3D electroanatomic mapping system
Receives: Device: Contact force guided ablation
Local impedance guided ablationActive comparatorThese patients will receive one catheter ablation of typical atrial flutter by local impedence guided radiofrequency ablation catheters using the Rhythmia Ultra-high density 3D electroanatomic mapping system
Receives: Device: Local impedance guide ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from first application of radiofrequency energy to confirmation of bidirectional cavotricuspid isthmus block

    Time from first application of radiofrequency energy to confirmation of bidirectional cavotricuspid isthmus block

    Measured: At time of procedure

Secondary outcomes (8)

  1. Mean total ablation time to achieve bidirectional cavotricuspid isthmus block

    Mean total ablation time to achieve bidirectional cavotricuspid isthmus block

    Measured: At time of procedure

  2. Mean total radiation exposure

    Mean total radiation exposure

    Measured: At time of procedure

  3. Mean total number of ablation lesions required to achieve bidirectional cavotricuspid isthmus block

    Mean total number of ablation lesions required to achieve bidirectional cavotricuspid isthmus block

    Measured: At time of procedure

  4. Number of cases where bidirectional cavotricuspid isthmus block was not achieved after the first pass of ablation

    Number of cases where bidirectional cavotricuspid isthmus block was not achieved after the first pass of ablation

    Measured: At time of procedure

  5. Mean time taken for second pass ablation (with or without the use of 3D mapping) to achieve bidirectional cavotricuspid isthmus block

    Mean time taken for second pass ablation (with or without the use of 3D mapping) to achieve bidirectional cavotricuspid isthmus block

    Measured: At time of procedure

  6. Locations of breakthrough across the initial ablation line

    Locations of breakthrough across the initial ablation line

    Measured: At time of procedure

  7. Frequency of procedural complications

    Frequency of procedural complications

    Measured: At time of and immediately following procedure

  8. Acute and medium-term success rates

    Acute and medium-term success rates

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2020
  2. Study start30 Oct 2022 (estimated)
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Why it stopped: Funding

Resources

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
114 patients randomised 1:1:1 to either fluoroscopically guided OR contact force guided OR local impedance guided radiofrequency catheter ablation of typical atrial flutter
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04434599
Sponsor's protocol ID
281105
Acronym
FLUTTER
Status last verified
Oct 2023
First submitted
10 Jun 2020
Last updated
1 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Fluoroscopically guided ablation, Contact force guided ablation and Local impedance guide ablation in people with Typical Atrial Flutter, run by University of Manchester.

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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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 from first application of radiofrequency energy to confirmation of bidirectional cavotricuspid isthmus block (time frame: At time of procedure). 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 NCT04434599.

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 1 Nov 2023.

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