Status:
WITHDRAWN
Fluoroscopic, Contact Force and Local Impedance With Ultra-high Density Mapping Guided Radiofrequency Ablation Comparison for cavoTricuspid Isthmus dependenT Atrial fluttER: the FLUTTER Study
Lead Sponsor:
University of Manchester
Collaborating Sponsors:
Manchester University NHS Foundation Trust
Conditions:
Typical Atrial Flutter
Eligibility:
All Genders
18-80 years
Phase:
NA
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 radiofreque...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04434599
Start Date
October 30 2022
End Date
January 1 2024
Last Update
November 1 2023
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