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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dhiraj Gupta, Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01445925
First received: September 30, 2011
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: Pulmonary vein isolation (PVI)
Procedure: Pulmonary vein isolation + linear lesions
Drug: Pharmacological Substrate modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Substrate Modification With Ablation and Antiarrhythmic Drugs in Non-Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Liverpool Heart and Chest Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Defined as >30 sec of AF/ atrial tachycardia identified on ECG or ambulatory ECG monitoring following a 3 month blanking period.


Estimated Enrollment: 130
Study Start Date: September 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pulmonary vein isolation
Patients will undergo pulmonary venous isolation plus pharmacological substrate modification
Procedure: Pulmonary vein isolation (PVI)
Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside pulmonary vein (PV) ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA). A 20-pole PV mapping catheter will be used to confirm electrical isolation. If the patient is in atrial fibrillation at this stage, sinus rhythm would be restored with electrical cardioversion and PVI would be confirmed in sinus rhythm
Drug: Pharmacological Substrate modification
at least 6 weeks therapy with oral amiodarone prior to the ablation procedure and 6 weeks post.
Experimental: Pulmonary vein isolation + Linear Lesions
Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification
Procedure: Pulmonary vein isolation + linear lesions
Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside PV ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA)34. A 20-pole PV mapping catheter will be used to confirm electrical isolation. Once PVI has been achieved, patients will go onto to receive additional linear ablation lesions. These will include a left atrial roof line, mitral isthmus line, (including ablation inside the coronary sinus if necessary), and ablation on the cavotricuspid isthmus. If the patient is in atrial fibrillation at this stage, the acute end-point would be signal obliteration at the ablated area. Once sinus rhythm is restored with electrical cardioversion, PVI would be confirmed in sinus rhythm and conduction block across the LA roof line, Mitral line and CTI will then be verified with appropriate pacing manoeuvres.
Drug: Pharmacological Substrate modification
at least 6 weeks therapy with oral amiodarone prior to the ablation procedure and 6 weeks post.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445925

Locations
United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom, L14 3PE
Royal Brompton and Harefield Hospitals NHS Trust
London, United Kingdom
Sponsors and Collaborators
Liverpool Heart and Chest Hospital NHS Foundation Trust
Investigators
Principal Investigator: Dhiraj Gupta, MD DM MRCP Liverpool Heart and Chest Hospital
  More Information

No publications provided

Responsible Party: Dhiraj Gupta, Consultant Cardiologist, Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01445925     History of Changes
Other Study ID Numbers: LHCH901
Study First Received: September 30, 2011
Last Updated: August 21, 2013
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014