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Funding
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| Name | Class |
|---|---|
| Manchester University NHS Foundation Trust | OTHER_GOV |
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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:
This prospective randomised study aims to compare these three standard of care procedures to determine if differences in ablation metrics, efficacy and safety exist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoroscopically guided ablation | Active Comparator | These patients will receive one catheter ablation of typical atrial flutter by fluoroscopically guided radiofrequency ablation catheters |
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| Contact force guided ablation | Active Comparator | These patients will receive one catheter ablation of typical atrial flutter by contact force guided radiofrequency ablation catheters using the CARTO 3D electroanatomic mapping system |
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| Local impedance guided ablation | Active Comparator | These 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoroscopically guided ablation | Device | Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by fluoroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mean total ablation time to achieve bidirectional cavotricuspid isthmus block | Mean total ablation time to achieve bidirectional cavotricuspid isthmus block | At time of procedure |
| Mean total radiation exposure |
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Inclusion Criteria:
Exclusion Criteria:
Pre-procedure:
Post procedure:
- arrhythmia mechanism found not to be cavotricuspid isthmus dependent atrial flutter
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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
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| Contact force guided ablation | Device | Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by contact force measurement and 3D electroanatomic mapping |
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| Local impedance guide ablation | Device | Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by local impedance measurement and ultra-high density 3D electroanatomic mapping |
|
Mean total radiation exposure
| 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 | 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 | 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 | At time of procedure |
| Locations of breakthrough across the initial ablation line | Locations of breakthrough across the initial ablation line | At time of procedure |
| Frequency of procedural complications | Frequency of procedural complications | At time of and immediately following procedure |
| Acute and medium-term success rates | Acute and medium-term success rates | 12 months |