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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04434599
Other study ID # 281105
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 30, 2022
Est. completion date January 1, 2024

Study information

Verified date October 2023
Source University of Manchester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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%. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 1, 2024
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fluoroscopically guided ablation
Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by fluoroscopy
Contact force guided ablation
Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by contact force measurement and 3D electroanatomic mapping
Local impedance guide ablation
Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by local impedance measurement and ultra-high density 3D electroanatomic mapping

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Manchester Manchester University NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Mean total ablation time to achieve bidirectional cavotricuspid isthmus block Mean total ablation time to achieve bidirectional cavotricuspid isthmus block At time of procedure
Secondary Mean total radiation exposure Mean total radiation exposure At time of procedure
Secondary 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
Secondary 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
Secondary 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
Secondary Locations of breakthrough across the initial ablation line Locations of breakthrough across the initial ablation line At time of procedure
Secondary Frequency of procedural complications Frequency of procedural complications At time of and immediately following procedure
Secondary Acute and medium-term success rates Acute and medium-term success rates 12 months
See also
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Completed NCT00984204 - Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL) Phase 3
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Completed NCT01408485 - Therapy™ Cool Flex™ Irrigated Ablation System for Typical Atrial Flutter N/A
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Recruiting NCT03867266 - Typical Atrial Flutter, Ablation Index and Point by Point Ablation
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