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

Phase 4

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: ILR insertion; Procedure: AF ablation

• Registration Number: NCT01504451
• Lead Sponsor: Neil Sulke

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-12-30
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-05
• Study Start: 2012-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26
• Primary Completion: 2015-04
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biosense Webster ablation	ILR insertion	Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation
Biosense Webster ablation	AF ablation	Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation
Surgical ablation	ILR insertion	Minimally invasive thoracoscopic surgical AF ablation
Surgical ablation	AF ablation	Minimally invasive thoracoscopic surgical AF ablation
Medtronic ablation	ILR insertion	Medtronic multi-electrode phased radiofrequency AF ablation
Medtronic ablation	AF ablation	Medtronic multi-electrode phased radiofrequency AF ablation

Primary Outcome Measures

Name	Time	Method
AF burden	12 months after ablation	Total proportion of time spent in AF as assessed by ILR

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Eastbourne General Hospital; 🇬🇧 Eastbourne, E Sussex, United Kingdom

Royal Sussex County Hospital; 🇬🇧 Brighton, Sussex, United Kingdom