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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pulmonary vein isolation (PVI)
Pulmonary vein isolation + linear lesions
Pharmacological Substrate modification
Sponsored by
Liverpool Heart and Chest Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Liverpool Heart and Chest Hospital
  • Royal Brompton and Harefield Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pulmonary vein isolation

Pulmonary vein isolation + Linear Lesions

Arm Description

Patients will undergo pulmonary venous isolation plus pharmacological substrate modification

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 30, 2011
Last Updated
August 21, 2013
Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01445925
Brief Title
Substrate Ablation and Remodelling in Non-paroxysmal Atrial Fibrillation (AF)
Acronym
SMAAN-PAF
Official Title
Substrate Modification With Ablation and Antiarrhythmic Drugs in Non-Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary vein isolation
Arm Type
Active Comparator
Arm Description
Patients will undergo pulmonary venous isolation plus pharmacological substrate modification
Arm Title
Pulmonary vein isolation + Linear Lesions
Arm Type
Experimental
Arm Description
Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation (PVI)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation + linear lesions
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pharmacological Substrate modification
Intervention Description
at least 6 weeks therapy with oral amiodarone prior to the ablation procedure and 6 weeks post.
Primary Outcome Measure Information:
Title
Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.
Description
Defined as >30 sec of AF/ atrial tachycardia identified on ECG or ambulatory ECG monitoring following a 3 month blanking period.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhiraj Gupta, MD DM MRCP
Organizational Affiliation
Liverpool Heart and Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
Royal Brompton and Harefield Hospitals NHS Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25588685
Citation
Wynn GJ, DAS M, Bonnett LJ, Hall MCS, Snowdon RL, Waktare JEP, Modi S, Todd DM, Gupta D. A novel marker to predict early recurrence after atrial fibrillation ablation: the ablation effectiveness quotient. J Cardiovasc Electrophysiol. 2015 Apr;26(4):397-403. doi: 10.1111/jce.12618. Epub 2015 Feb 25.
Results Reference
derived

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

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