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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Pulmonary vein isolation (PVI); Procedure: Pulmonary vein isolation + linear lesions; Drug: Pharmacological Substrate modification

• Registration Number: NCT01445925
• Lead Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-30
• Study First Submitted QC: 2011-10-03
• Study First Posted: 2011-10-04
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-21
• Last Update Posted: 2013-08-22
• Primary Completion: 2014-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary vein isolation	Pulmonary vein isolation (PVI)	Patients will undergo pulmonary venous isolation plus pharmacological substrate modification
Pulmonary vein isolation	Pharmacological Substrate modification	Patients will undergo pulmonary venous isolation plus pharmacological substrate modification
Pulmonary vein isolation + Linear Lesions	Pulmonary vein isolation + linear lesions	Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification
Pulmonary vein isolation + Linear Lesions	Pharmacological Substrate modification	Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification

Primary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.	12 months	Defined as \>30 sec of AF/ atrial tachycardia identified on ECG or ambulatory ECG monitoring following a 3 month blanking period.

Trial Locations

Locations (2)

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, United Kingdom

Royal Brompton and Harefield Hospitals NHS Trust; 🇬🇧 London, United Kingdom