Substrate Ablation and Remodelling in Non-paroxysmal Atrial Fibrillation (AF)

• Status: Unknown status
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

Criteria

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