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

June 25, 2014 updated by: Neil Sulke

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • E Sussex
      • Eastbourne, E Sussex, United Kingdom, BN21 2UD
        • Eastbourne General Hospital
    • Sussex
      • Brighton, Sussex, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Biosense Webster ablation
Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation
Device: ILR insertion
Insertion of implantable loop recorder
Procedure: AF ablation
AF ablation
ACTIVE_COMPARATOR: Surgical ablation
Minimally invasive thoracoscopic surgical AF ablation
Device: ILR insertion
Insertion of implantable loop recorder
Procedure: AF ablation
AF ablation
ACTIVE_COMPARATOR: Medtronic ablation
Medtronic multi-electrode phased radiofrequency AF ablation
Device: ILR insertion
Insertion of implantable loop recorder
Procedure: AF ablation
AF ablation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neil Sulke

Investigators

  • Principal Investigator: Stephen S Furniss, MD, Eastbourne General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

April 1, 2015

Study Completion (ANTICIPATED)

May 1, 2015

Study Registration Dates

First Submitted

December 30, 2011

First Submitted That Met QC Criteria

January 3, 2012

First Posted (ESTIMATE)

January 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAAPITUP 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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