Status:
WITHDRAWN
RandOmised Controlled Trial of STAR Mapping™ Guided Ablation for AF.
Lead Sponsor:
Rhythm AI Ltd
Collaborating Sponsors:
Biosense Webster, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Beyond causing troublesome symptoms AF is associated with increased mortality and morbi...
Detailed Description
This will be a prospective multi-centre randomised controlled trial with two treatment arms. We plan to include up to 15 UK centres. Patients that have been referred for catheter ablation of symptomat...
Eligibility Criteria
Inclusion
- Persistent AF (continuous AF duration between 1 week and 24 months)
- No previous AF ablation or other left atrial ablation
- Undergoing a clinical AF ablation procedure.
Exclusion
- Unwillingness to sign consent
- Any other contraindication to catheter ablation
- Age \<18 years or \> 80 years
- AF with a reversible cause
- AF that is paroxysmal
- AF that has been persistent \> 2 yrs
- Previous left atrial ablation (percutaneous or surgical)
- Severe LV impairment (EF \< 40%)
- NYHA class 3 or 4 heart failure
- Severely dilated left atrium (LA diameter \> 50 mm)
- Known cardiomyopathy or inherited 'channelopathy'
- Congential heart disease (excluding PFO)
- More than moderate valvular heart disease or prosthetic heart valves
- Prior MI, PCI or cardiac surgery in the last 6 months
- Pregnancy
- Morbid obesity (defined as BMI \>40)
- Any other medical problem likely to cause death within the next 18 months
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04442113
Start Date
December 1 2021
End Date
September 1 2022
Last Update
April 14 2021
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