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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biosense Webster ablation

Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation

Group Type ACTIVE_COMPARATOR

ILR insertion

Intervention Type DEVICE

Insertion of implantable loop recorder

AF ablation

Intervention Type PROCEDURE

AF ablation

Surgical ablation

Minimally invasive thoracoscopic surgical AF ablation

Group Type ACTIVE_COMPARATOR

ILR insertion

Intervention Type DEVICE

Insertion of implantable loop recorder

AF ablation

Intervention Type PROCEDURE

AF ablation

Medtronic ablation

Medtronic multi-electrode phased radiofrequency AF ablation

Group Type ACTIVE_COMPARATOR

ILR insertion

Intervention Type DEVICE

Insertion of implantable loop recorder

AF ablation

Intervention Type PROCEDURE

AF ablation

Interventions

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ILR insertion

Insertion of implantable loop recorder

Intervention Type DEVICE

AF ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No