Clinical trial NCT01504451: Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study
Official title: Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Atrial fibrillation
Ablation
Implantable loop recorder
Lead sponsor: Eastbourne General Hospital
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: AF burden
timeFrame: 12 months after ablation
Secondary outcomes:
measure: Time to AF recurrence
timeFrame: Up to one year
measure: Time to first symptomatic AF recurrence
timeFrame: Up to one year
measure: Change in QoL measures
timeFrame: 12 months after ablation
Other outcomes:
Locations:
city: Eastbourne
country: United Kingdom
facility: Eastbourne General Hospital
state: E Sussex
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
state: Sussex
Study officials:
affiliation: Eastbourne General Hospital
name: Neil Sulke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastbourne General Hospital
name: Stephen S Furniss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sugihara C, Furniss S, Hyde J, Lewis M, Sulke N. Results of the first investigator-initiated randomized clinical trial of nMARQTM, PVACTM, and thoracoscopic ablation for paroxysmal atrial fibrillation. Europace. 2018 Nov 1;20(FI_3):f384-f391. doi: 10.1093/europace/eux267.