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

Neil Sulke

Status and phase: Unknown; Phase 4

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: ILR insertion; Procedure: AF ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01504451

LAAPITUP 2

Details and patient eligibility

About

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 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Biosense Webster ablation

Active Comparator group

Description:

Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation

Treatment:

Procedure: AF ablation

Device: ILR insertion

Surgical ablation

Active Comparator group

Description:

Minimally invasive thoracoscopic surgical AF ablation

Treatment:

Procedure: AF ablation

Device: ILR insertion

Medtronic ablation

Active Comparator group

Description:

Medtronic multi-electrode phased radiofrequency AF ablation

Treatment:

Procedure: AF ablation

Device: ILR insertion