Clinical trial NCT04434599: Fluoroscopic, Contact Force and Local Impedance With Ultra-high Density Mapping Guided Radiofrequency Ablation Comparison for cavoTricuspid Isthmus dependenT Atrial fluttER: the FLUTTER Study
Official title: Fluoroscopic, Contact Force and Local Impedance With Ultra-high Density Mapping Guided Radiofrequency Ablation Comparison for cavoTricuspid Isthmus dependenT Atrial fluttER: the FLUTTER Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Typical Atrial Flutter
Keywords: radiofrequency ablation
contact force
local impedance
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2020-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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%. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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
* 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

Primary outcomes:
measure: Time from first application of radiofrequency energy to confirmation of bidirectional cavotricuspid isthmus block
timeFrame: At time of procedure
Secondary outcomes:
measure: Mean total ablation time to achieve bidirectional cavotricuspid isthmus block
timeFrame: At time of procedure
measure: Mean total radiation exposure
timeFrame: At time of procedure
measure: Mean total number of ablation lesions required to achieve bidirectional cavotricuspid isthmus block
timeFrame: At time of procedure
measure: Number of cases where bidirectional cavotricuspid isthmus block was not achieved after the first pass of ablation
timeFrame: At time of procedure
measure: Mean time taken for second pass ablation (with or without the use of 3D mapping) to achieve bidirectional cavotricuspid isthmus block
timeFrame: At time of procedure
measure: Locations of breakthrough across the initial ablation line
timeFrame: At time of procedure
measure: Frequency of procedural complications
timeFrame: At time of and immediately following procedure
measure: Acute and medium-term success rates
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
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