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

Paroxysmal Atrial Fibrillation Clinical Trial

— LAAPITUP 2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01504451
• Other study ID #: LAAPITUP 2
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 30, 2011
• Last updated: June 25, 2014
• Start date: April 2012
• Est. completion date: May 2015

Study information

• Verified date: June 2014
• Source: Eastbourne General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• ILR insertion
Insertion of implantable loop recorder

Procedure:
• AF ablation
AF ablation

Locations

Country	Name	City	State
United Kingdom	Royal Sussex County Hospital	Brighton	Sussex
United Kingdom	Eastbourne General Hospital	Eastbourne	E Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Neil Sulke

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF burden	Total proportion of time spent in AF as assessed by ILR	12 months after ablation	No
Secondary	Time to AF recurrence	Time to recurrence of any AF after ablation	Up to one year	No
Secondary	Time to first symptomatic AF recurrence	Time to first symptomatic AF recurrence as assessed by ILR.	Up to one year	No
Secondary	Change in QoL measures	Change in Quality of Life measures assessed by questionnaire.	12 months after ablation	No