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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by fluoroscopy
Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by contact force measurement and 3D electroanatomic mapping
Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by local impedance measurement and ultra-high density 3D electroanatomic mapping
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
Time frame: At time of procedure
Mean total ablation time to achieve bidirectional cavotricuspid isthmus block
Mean total ablation time to achieve bidirectional cavotricuspid isthmus block
Time frame: At time of procedure
Mean total radiation exposure
Mean total radiation exposure
Time frame: At time of procedure
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
Time frame: At time of procedure
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
Time frame: At time of procedure
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
Time frame: At time of procedure
Locations of breakthrough across the initial ablation line
Locations of breakthrough across the initial ablation line
Time frame: At time of procedure
Frequency of procedural complications
Frequency of procedural complications
Time frame: At time of and immediately following procedure
Acute and medium-term success rates
Acute and medium-term success rates
Time frame: 12 months
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