Overview

This trial is active, not recruiting.

Condition paroxysmal atrial fibrillation
Treatments ilr insertion, af ablation
Phase phase 4
Sponsor Neil Sulke
Start date April 2012
End date April 2015
Trial size 75 participants
Trial identifier NCT01504451, LAAPITUP 2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation
ilr insertion
Insertion of implantable loop recorder
af ablation
AF ablation
(Active Comparator)
Minimally invasive thoracoscopic surgical AF ablation
ilr insertion
Insertion of implantable loop recorder
af ablation
AF ablation
(Active Comparator)
Medtronic multi-electrode phased radiofrequency AF ablation
ilr insertion
Insertion of implantable loop recorder
af ablation
AF ablation

Primary Outcomes

Measure
AF burden
time frame: 12 months after ablation

Secondary Outcomes

Measure
Time to AF recurrence
time frame: Up to one year
Time to first symptomatic AF recurrence
time frame: Up to one year
Change in QoL measures
time frame: 12 months after ablation

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2
Principal investigator Neil Sulke, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Eastbourne General Hospital.