Substrate Ablation and Remodelling in Non-paroxysmal Atrial Fibrillation (AF)
This trial is active, not recruiting.
|Treatments||pulmonary vein isolation (pvi), pulmonary vein isolation + linear lesions, pharmacological substrate modification|
|Sponsor||Liverpool Heart and Chest Hospital NHS Foundation Trust|
|Start date||September 2011|
|End date||November 2014|
|Trial size||130 participants|
|Trial identifier||NCT01445925, LHCH901|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.
time frame: 12 months
Male or female participants at least 18 years old.
- 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
- 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
|Official title||Substrate Modification With Ablation and Antiarrhythmic Drugs in Non-Paroxysmal Atrial Fibrillation|
|Principal investigator||Dhiraj Gupta, MD DM MRCP|
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