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Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP (LAAPITUP)

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
AF Ablation with Ablation Frontiers Technology
AF Ablation with LASSO catheter
Reveal XT
Permanent Dual Chamber Pacemaker
Sponsored by
Eastbourne General Hospital
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, Atrial Fibrillation Ablation, Atrial Fibrillation monitoring, Ablation Frontiers, Reveal XT, LASSO

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient aged 16-80 years old.
  • Symptomatic PAF with AF episodes self terminating after at least 30 seconds but not longer than 24 hours. Preference is given to patients with AF episodes lasting no longer than 4 hours.
  • PAF should have failed at least one drug therapy medical therapy.
  • Patients must give written informed consent form prior to participating in this study.

Exclusion Criteria:

  • Patient is suffering with unstable angina in last 1 week.
  • Patient has had a myocardial infarction within last 2 months.
  • Patient is expecting or has had major cardiac surgery within last 2 months.
  • Patient is participating in a conflicting study.
  • Patient is mentally incapacitated and cannot consent or comply with follow-up.
  • Patient has NYHA class III/ IV heart failure.
  • Patients with severe valvular or ventricular dysfunction.
  • Pregnancy.
  • Patient suffers with other cardiac rhythm disorders.
  • Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings)

Sites / Locations

  • Eastbourne District General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Ablation Frontiers Ablation

LASSO ablation

Reveal XT monitoring

Permanent Pacemaker - dual chamber

Arm Description

This group will undergo AF ablation using Ablation Frontiers Technology.

This group will undergo atrial fibrillation ablation with traditional LASSO technology

This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder.

This group will be monitored pre and post ablation with a dual chamber permanent pacemaker

Outcomes

Primary Outcome Measures

AF Burden
AF Burden post left atrial ablation is defined as the sum of the duration of all atrial tachyarrhythmias expressed as a percentage of the total observation period as assessed by PM Holters.
AF Burden
Comparison of AF burden post PVI ablation using a conventional irrigation tip catheter with LASSO guidance (or equivalent) versus Ablation Frontiers Technology using the PVAC, MASC and TVAC catheters via standard trans-septal techniques.
AF Burden detected
To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.

Secondary Outcome Measures

Arrhythmia frequency - symptomatic or asymptomatic.
Arrhythmia Frequency is defined as the total number of atrial tachyarrhythmic episodes divided by the observation period, expressed as episodes per day as assessed by PM Holters.
Time to first episode of AF
Time to persistent AF is defined as the time from ablation to the first recorded episode of AF
Average AF duration
Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes.
Time to persistent AF.
Time to persistent AF (atrial fibrillation episode lasting for 7 days)
Average SR duration.
Average sinus rhythm duration is defined as the total duration of sinus rhythm from first atrial arrhythmic episode until last atrial arrhythmic episode divided by the number of atrial arrhythmic episodes minus 1.

Full Information

First Posted
March 29, 2010
Last Updated
March 29, 2010
Sponsor
Eastbourne General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01095770
Brief Title
Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP
Acronym
LAAPITUP
Official Title
Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Eastbourne General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is 3 fold:- To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF. To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter. To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.

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, Atrial Fibrillation Ablation, Atrial Fibrillation monitoring, Ablation Frontiers, Reveal XT, LASSO

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ablation Frontiers Ablation
Arm Type
Active Comparator
Arm Description
This group will undergo AF ablation using Ablation Frontiers Technology.
Arm Title
LASSO ablation
Arm Type
Active Comparator
Arm Description
This group will undergo atrial fibrillation ablation with traditional LASSO technology
Arm Title
Reveal XT monitoring
Arm Type
Active Comparator
Arm Description
This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder.
Arm Title
Permanent Pacemaker - dual chamber
Arm Type
Active Comparator
Arm Description
This group will be monitored pre and post ablation with a dual chamber permanent pacemaker
Intervention Type
Procedure
Intervention Name(s)
AF Ablation with Ablation Frontiers Technology
Intervention Description
AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.
Intervention Type
Procedure
Intervention Name(s)
AF Ablation with LASSO catheter
Intervention Description
AF Ablation with traditional LASSO catheter
Intervention Type
Device
Intervention Name(s)
Reveal XT
Intervention Description
Reveal XT implantable loop recorder monitored group
Intervention Type
Device
Intervention Name(s)
Permanent Dual Chamber Pacemaker
Intervention Description
This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.
Primary Outcome Measure Information:
Title
AF Burden
Description
AF Burden post left atrial ablation is defined as the sum of the duration of all atrial tachyarrhythmias expressed as a percentage of the total observation period as assessed by PM Holters.
Time Frame
12 Months
Title
AF Burden
Description
Comparison of AF burden post PVI ablation using a conventional irrigation tip catheter with LASSO guidance (or equivalent) versus Ablation Frontiers Technology using the PVAC, MASC and TVAC catheters via standard trans-septal techniques.
Time Frame
12 months
Title
AF Burden detected
Description
To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Arrhythmia frequency - symptomatic or asymptomatic.
Description
Arrhythmia Frequency is defined as the total number of atrial tachyarrhythmic episodes divided by the observation period, expressed as episodes per day as assessed by PM Holters.
Time Frame
12 months
Title
Time to first episode of AF
Description
Time to persistent AF is defined as the time from ablation to the first recorded episode of AF
Time Frame
12 months
Title
Average AF duration
Description
Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes.
Time Frame
12 months
Title
Time to persistent AF.
Description
Time to persistent AF (atrial fibrillation episode lasting for 7 days)
Time Frame
12 months
Title
Average SR duration.
Description
Average sinus rhythm duration is defined as the total duration of sinus rhythm from first atrial arrhythmic episode until last atrial arrhythmic episode divided by the number of atrial arrhythmic episodes minus 1.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged 16-80 years old. Symptomatic PAF with AF episodes self terminating after at least 30 seconds but not longer than 24 hours. Preference is given to patients with AF episodes lasting no longer than 4 hours. PAF should have failed at least one drug therapy medical therapy. Patients must give written informed consent form prior to participating in this study. Exclusion Criteria: Patient is suffering with unstable angina in last 1 week. Patient has had a myocardial infarction within last 2 months. Patient is expecting or has had major cardiac surgery within last 2 months. Patient is participating in a conflicting study. Patient is mentally incapacitated and cannot consent or comply with follow-up. Patient has NYHA class III/ IV heart failure. Patients with severe valvular or ventricular dysfunction. Pregnancy. Patient suffers with other cardiac rhythm disorders. Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven J Podd, MBBS, MRCP, BA
Phone
01323 417400
Ext
4132
Email
steven.podd@esht.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen S Furniss, FRCP, MD
Organizational Affiliation
East Sussex NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AN Sulke, FRCP, MD
Organizational Affiliation
East Sussex NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastbourne District General Hospital
City
Eastbourne
State/Province
East Sussex
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven J Podd, MBBS, MA, MRCP
Phone
01323 417400
Ext
4132
Email
steven.podd@esht.nhs.uk
First Name & Middle Initial & Last Name & Degree
Steven J Podd, MBBS, MA, MRCP

12. IPD Sharing Statement

Citations:
PubMed Identifier
26310300
Citation
Podd SJ, Sulke AN, Sugihara C, Furniss SS. Phased multipolar radiofrequency pulmonary vein isolation is as effective and safe as conventional irrigated point-to-point ablation. A prospective randomised 1-year implantable cardiac monitoring device follow-up trial. J Interv Card Electrophysiol. 2015 Dec;44(3):257-64. doi: 10.1007/s10840-015-0042-0. Epub 2015 Aug 27.
Results Reference
derived

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Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP

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