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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
ILR insertion
AF ablation
Sponsored by
Neil Sulke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Atrial fibrillation, Ablation, Implantable loop recorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Eastbourne General Hospital
  • Royal Sussex County Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Biosense Webster ablation

Surgical ablation

Medtronic ablation

Arm Description

Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation

Minimally invasive thoracoscopic surgical AF ablation

Medtronic multi-electrode phased radiofrequency AF ablation

Outcomes

Primary Outcome Measures

AF burden
Total proportion of time spent in AF as assessed by ILR

Secondary Outcome Measures

Time to AF recurrence
Time to recurrence of any AF after ablation
Time to first symptomatic AF recurrence
Time to first symptomatic AF recurrence as assessed by ILR.
Change in QoL measures
Change in Quality of Life measures assessed by questionnaire.

Full Information

First Posted
December 30, 2011
Last Updated
June 25, 2014
Sponsor
Neil Sulke
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1. Study Identification

Unique Protocol Identification Number
NCT01504451
Brief Title
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study
Acronym
LAAPITUP 2
Official Title
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Neil Sulke

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Atrial fibrillation, Ablation, Implantable loop recorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biosense Webster ablation
Arm Type
Active Comparator
Arm Description
Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation
Arm Title
Surgical ablation
Arm Type
Active Comparator
Arm Description
Minimally invasive thoracoscopic surgical AF ablation
Arm Title
Medtronic ablation
Arm Type
Active Comparator
Arm Description
Medtronic multi-electrode phased radiofrequency AF ablation
Intervention Type
Device
Intervention Name(s)
ILR insertion
Intervention Description
Insertion of implantable loop recorder
Intervention Type
Procedure
Intervention Name(s)
AF ablation
Intervention Description
AF ablation
Primary Outcome Measure Information:
Title
AF burden
Description
Total proportion of time spent in AF as assessed by ILR
Time Frame
12 months after ablation
Secondary Outcome Measure Information:
Title
Time to AF recurrence
Description
Time to recurrence of any AF after ablation
Time Frame
Up to one year
Title
Time to first symptomatic AF recurrence
Description
Time to first symptomatic AF recurrence as assessed by ILR.
Time Frame
Up to one year
Title
Change in QoL measures
Description
Change in Quality of Life measures assessed by questionnaire.
Time Frame
12 months after ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Sulke, MD
Organizational Affiliation
Eastbourne General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen S Furniss, MD
Organizational Affiliation
Eastbourne General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastbourne General Hospital
City
Eastbourne
State/Province
E Sussex
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
State/Province
Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29092038
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.
Results Reference
derived

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

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