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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Dhiraj Gupta, Liverpool Heart and Chest Hospital NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01445925
First Posted: October 4, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dhiraj Gupta, Liverpool Heart and Chest Hospital NHS Foundation Trust
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Dhiraj Gupta, 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 ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: September 30, 2011
First Posted: October 4, 2011
Last Update Posted: October 12, 2017
Last Verified: August 2013

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes