Status:
COMPLETED
Left Atrial Arrhythmia Substrate Identification After Confirmed durABLE Pulmonary Vein Isolation
Lead Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Atrial Fibrillation
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Under current practice, patients with persistent atrial fibrillation, can be offered one of two types of ablation treatment. Both of these treatments are aimed at electrically isolating the 4 pulmonar...
Detailed Description
Persistent atrial fibrillation (PeAF) is defined as continuous atrial fibrillation for 7 days or more. Approximately 10% of people are diagnosed with atrial fibrillation (AF) by age 80 years; and amon...
Eligibility Criteria
Inclusion
- Age 18 to 80 years
- Evidence of persistent Atrial Fibrillation
Exclusion
- Any previous catheter (or surgical) ablation for atrial fibrillation or cryoballoon pulmonary vein isolation
- An indwelling atrial septal defect (ASD) occluder device or anatomical structure that pre-vents free access to the left atrium
- Left atrial diameter on transthoracic echo (Parasternal long axis, M-mode) \> 5.5cm
- Recent stroke/Transient Ischaemic Attack within 3 months
- Inability, unwillingness or absolute contraindication to taking oral anticoagulant medication
- Severe kidney impairment (estimated Glomerular Filtration Rate \< 30ml/min)
- Morbid obesity (Body Mass Index ≥40)
- Extreme frailty
- Severe valvular heart disease of any kind as assessed by the investigator, with or without prosthetic valve in place
- Pregnancy
Key Trial Info
Start Date :
March 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04111731
Start Date
March 3 2020
End Date
March 11 2024
Last Update
September 25 2025
Active Locations (3)
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1
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom, L14 3PE
2
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
3
The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN