Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study

Overview

This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.

Full Title of Study: “Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2015

Detailed Description

A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.

Interventions

  • Device: ILR insertion
    • Insertion of implantable loop recorder
  • Procedure: AF ablation
    • AF ablation

Arms, Groups and Cohorts

  • Active Comparator: Biosense Webster ablation
    • Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation
  • Active Comparator: Surgical ablation
    • Minimally invasive thoracoscopic surgical AF ablation
  • Active Comparator: Medtronic ablation
    • Medtronic multi-electrode phased radiofrequency AF ablation

Clinical Trial Outcome Measures

Primary Measures

  • AF burden
    • Time Frame: 12 months after ablation
    • Total proportion of time spent in AF as assessed by ILR

Secondary Measures

  • Time to AF recurrence
    • Time Frame: Up to one year
    • Time to recurrence of any AF after ablation
  • Time to first symptomatic AF recurrence
    • Time Frame: Up to one year
    • Time to first symptomatic AF recurrence as assessed by ILR.
  • Change in QoL measures
    • Time Frame: 12 months after ablation
    • Change in Quality of Life measures assessed by questionnaire.

Participating in This Clinical Trial

Inclusion Criteria

  • Symptomatic paroxysmal AF suitable for AF ablation – Age > 18 years old – Informed consent to participate in this study. Exclusion Criteria:

  • Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe. – Unable to undergo general anaesthesia for AF ablation. – Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery. – Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery. – Previous thoracic surgery. – Participation in a conflicting study. – Potential participants who are mentally incapacitated and cannot consent or comply with follow-up – Pregnancy – Other cardiac rhythm disorders

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Neil Sulke
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Neil Sulke, Consultant Cardiologist – Eastbourne General Hospital
  • Overall Official(s)
    • Neil Sulke, MD, Principal Investigator, Eastbourne General Hospital
    • Stephen S Furniss, MD, Principal Investigator, Eastbourne General Hospital

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