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

Liverpool Heart and Chest Hospital NHS Foundation Trust

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: Pulmonary vein isolation (PVI); Drug: Pharmacological Substrate modification; Procedure: Pulmonary vein isolation + linear lesions

Study type: Interventional

Funder types: Other

Identifiers

NCT01445925

LHCH901

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Pulmonary vein isolation

Active Comparator group

Description:

Patients will undergo pulmonary venous isolation plus pharmacological substrate modification

Treatment:

Drug: Pharmacological Substrate modification

Procedure: Pulmonary vein isolation (PVI)

Pulmonary vein isolation + Linear Lesions

Experimental group

Description:

Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification

Treatment:

Procedure: Pulmonary vein isolation + linear lesions

Drug: Pharmacological Substrate modification