Status:
WITHDRAWN
Reduction in Arrhythmia Burden With Left Atrial Posterior Wall Ablation for Persistent AF
Lead Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborating Sponsors:
Biosense Webster, Inc.
Royal Brompton & Harefield NHS Foundation Trust
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).
Detailed Description
Ablation for AF has a high success rate for patients with paroxysmal AF, but success rates for persistent AF remain significantly lower. These patients frequently have more advanced disease in their l...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 18 to 80 (inclusive)
- Patients with symptomatic advanced persistent AF, defined as:
- AF which does not spontaneously terminate and requires medical intervention (antiarrhythmics or DCCV) to terminate, AND
- Recurs following cardioversion, AND
- Is associated with evidence of left atrial cardiopathy, defined as at least mild left atrial enlargement on imaging (echo, CT or MRI) as defined by standard values (for example British Society of Echocardiography or European equivalent) - in the event of uncertainty, Principal Investigator discretion is allowed.
- Exclusion Criteria
- Any previous catheter (or surgical) ablation for AF (previous ablation for atrial flutter or focal atrial tachycardias are allowable)
- An indwelling atrial septal defect occluder device or anatomical structure that pre-vents free access to the left atrium
- Severe left ventricular systolic dysfunction (ejection fraction less than 35%)
- Recent stroke/transient ischaemic attack within 3 months
- Inability, unwillingness or absolute contraindication to taking an oral anticoagulant medication
- Severe kidney function impairment (eGFR less than 30ml/min/1.73m2)
- Morbid obesity with a body mass index ≥40
- Extreme frailty (a score of 7,8 or 9 on the Rockwood Clinical Frailty Scale)
- Severe valvular heart disease of any kind as assessed by the investigator, with or without a prosthetic valve in place
- Pregnancy
Exclusion
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05195268
Start Date
July 1 2022
End Date
September 12 2022
Last Update
September 29 2022
Active Locations (1)
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1
Liverpool Heart & Chest Hospital
Liverpool, United Kingdom, L14 3PE