Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP

Overview

The purpose of this study is 3 fold:- 1. To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF. 2. To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter. 3. To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2012

Interventions

  • Procedure: AF Ablation with Ablation Frontiers Technology
    • AF Ablation with Ablation Frontiers Technology – PVAC, TVAC and MASC.
  • Procedure: AF Ablation with LASSO catheter
    • AF Ablation with traditional LASSO catheter
  • Device: Reveal XT
    • Reveal XT implantable loop recorder monitored group
  • Device: Permanent Dual Chamber Pacemaker
    • This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.

Arms, Groups and Cohorts

  • Active Comparator: Ablation Frontiers Ablation
    • This group will undergo AF ablation using Ablation Frontiers Technology.
  • Active Comparator: LASSO ablation
    • This group will undergo atrial fibrillation ablation with traditional LASSO technology
  • Active Comparator: Reveal XT monitoring
    • This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder.
  • Active Comparator: Permanent Pacemaker – dual chamber
    • This group will be monitored pre and post ablation with a dual chamber permanent pacemaker

Clinical Trial Outcome Measures

Primary Measures

  • AF Burden
    • Time Frame: 12 Months
    • AF Burden post left atrial ablation is defined as the sum of the duration of all atrial tachyarrhythmias expressed as a percentage of the total observation period as assessed by PM Holters.
  • AF Burden
    • Time Frame: 12 months
    • Comparison of AF burden post PVI ablation using a conventional irrigation tip catheter with LASSO guidance (or equivalent) versus Ablation Frontiers Technology using the PVAC, MASC and TVAC catheters via standard trans-septal techniques.
  • AF Burden detected
    • Time Frame: 12 months
    • To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the ‘gold standard’ DDD pacemaker Holter.

Secondary Measures

  • Arrhythmia frequency – symptomatic or asymptomatic.
    • Time Frame: 12 months
    • Arrhythmia Frequency is defined as the total number of atrial tachyarrhythmic episodes divided by the observation period, expressed as episodes per day as assessed by PM Holters.
  • Time to first episode of AF
    • Time Frame: 12 months
    • Time to persistent AF is defined as the time from ablation to the first recorded episode of AF
  • Average AF duration
    • Time Frame: 12 months
    • Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes.
  • Time to persistent AF.
    • Time Frame: 12 months
    • Time to persistent AF (atrial fibrillation episode lasting for 7 days)
  • Average SR duration.
    • Time Frame: 12 months
    • Average sinus rhythm duration is defined as the total duration of sinus rhythm from first atrial arrhythmic episode until last atrial arrhythmic episode divided by the number of atrial arrhythmic episodes minus 1.

Participating in This Clinical Trial

Inclusion Criteria

  • Patient aged 16-80 years old. – Symptomatic PAF with AF episodes self terminating after at least 30 seconds but not longer than 24 hours. Preference is given to patients with AF episodes lasting no longer than 4 hours. – PAF should have failed at least one drug therapy medical therapy. – Patients must give written informed consent form prior to participating in this study. Exclusion Criteria:

  • Patient is suffering with unstable angina in last 1 week. – Patient has had a myocardial infarction within last 2 months. – Patient is expecting or has had major cardiac surgery within last 2 months. – Patient is participating in a conflicting study. – Patient is mentally incapacitated and cannot consent or comply with follow-up. – Patient has NYHA class III/ IV heart failure. – Patients with severe valvular or ventricular dysfunction. – Pregnancy. – Patient suffers with other cardiac rhythm disorders. – Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings)

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eastbourne General Hospital
  • Provider of Information About this Clinical Study
    • Dr AN Sulke, East Sussex NHS Trust
  • Overall Official(s)
    • Stephen S Furniss, FRCP, MD, Principal Investigator, East Sussex NHS Trust
    • AN Sulke, FRCP, MD, Principal Investigator, East Sussex NHS Trust
  • Overall Contact(s)
    • Steven J Podd, MBBS, MRCP, BA, 01323 417400, steven.podd@esht.nhs.uk

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