Substrate Modification With Ablation and Antiarrhythmic Drugs in Non-Paroxysmal Atrial Fibrillation
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.
Study Overview
Brief Summary
The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by radiofrequency ablation would improve single procedure success rates for Radio Frequency Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term peri-procedural anti-arrhythmic drug therapy alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ongoing symptoms (European Heart Rhythm Association Class 2 or above) in spite of treatment with rate control medication
- •Non-paroxysmal atrial fibrillation, as pre-classified as
- •Persistent AF: AF requiring Electrical/ Chemical cardioversion or that lasting >7 days. These patients may be in AF or in sinus Rhythm at the time of their initial assessment and/ or at the time of their ablation.
- •Continuous Persistent AF: These patients are persistently in AF with or without antiarrhythmic drug therapy, as confirmed on a 24 hour Holter. They may have undergone previous cardioversion(s).
- •Sustained Paroxysmal AF with underlying substrate: Patients with Individual AF episode(s) lasting >12 hours but less than 7 days plus one or more of the following:
- •Age >65 years 21
- •Individual AF episode(s) lasting >24 hours
- •Significant left atrial dilatation of >45 mm on Echo (Parasternal Long Axis view)
- •Obesity (Body Mass Index >30), and/ or history suggestive of sleep apnoea
- •Diabetes Mellitus requiring hypoglycaemic drugs and/or Insulin
Exclusion Criteria
- •Inability or unwillingness to receive oral anticoagulation with warfarin
- •Previous Ablation procedure for AF
- •Unwillingness or inability to complete the required follow up arrangements
- •Presence of long standing persistent AF with continuous AF longer than 12 months. This includes patients in whom sinus rhythm may have been maintained following electrical cardioversion for a period of less than 1 week at a stretch.
- •Documented typical atrial flutter
- •Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
- •Contraindications and/ or prior intolerance to both Amiodarone and Flecainide.
- •Reversible cause for atrial fibrillation
- •Known hypertrophic or infiltrative cardiomyopathy
Arms & Interventions
Pulmonary vein isolation
Patients will undergo pulmonary venous isolation plus pharmacological substrate modification
Intervention: Pulmonary vein isolation (PVI) (Procedure)
Pulmonary vein isolation
Patients will undergo pulmonary venous isolation plus pharmacological substrate modification
Intervention: Pharmacological Substrate modification (Drug)
Pulmonary vein isolation + Linear Lesions
Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification
Intervention: Pulmonary vein isolation + linear lesions (Procedure)
Pulmonary vein isolation + Linear Lesions
Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification
Intervention: Pharmacological Substrate modification (Drug)
Outcomes
Primary Outcomes
Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.
Time Frame: 12 months
Defined as \>30 sec of AF/ atrial tachycardia identified on ECG or ambulatory ECG monitoring following a 3 month blanking period.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dhiraj Gupta
Consultant Cardiologist
Liverpool Heart and Chest Hospital NHS Foundation Trust