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

The purpose of this study is 3 fold:-

1. 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.
2. To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
3. To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.

Study Overview

• Status: Unknown
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: AF Ablation with Ablation Frontiers Technology; Procedure: AF Ablation with LASSO catheter; Device: Reveal XT; Device: Permanent Dual Chamber Pacemaker

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • East Sussex
    • Eastbourne, East Sussex, United Kingdom, BN21 2UD
      • Eastbourne District General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ablation Frontiers Ablation; This group will undergo AF ablation using Ablation Frontiers Technology.	Procedure: AF Ablation with Ablation Frontiers Technology; AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.
Active Comparator: LASSO ablation; This group will undergo atrial fibrillation ablation with traditional LASSO technology	Procedure: AF Ablation with LASSO catheter; AF Ablation with traditional LASSO catheter
Active Comparator: Reveal XT monitoring; This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder.	Device: Reveal XT; Reveal XT implantable loop recorder monitored group
Active Comparator: Permanent Pacemaker - dual chamber; This group will be monitored pre and post ablation with a dual chamber permanent pacemaker	Device: Permanent Dual Chamber Pacemaker; This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 Months
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.	12 months
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Time to first episode of AF	Time to persistent AF is defined as the time from ablation to the first recorded episode of AF	12 months
Average AF duration	Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes.	12 months
Time to persistent AF.	Time to persistent AF (atrial fibrillation episode lasting for 7 days)	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Eastbourne General Hospital
• Investigators: Principal Investigator: Stephen S Furniss, FRCP, MD, East Sussex NHS Trust; Principal Investigator: AN Sulke, FRCP, MD, East Sussex NHS Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: March 29, 2010
• First Submitted That Met QC Criteria: March 29, 2010
• First Posted (Estimate): March 30, 2010

Study Record Updates

• Last Update Posted (Estimate): March 30, 2010
• Last Update Submitted That Met QC Criteria: March 29, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Atrial Fibrillation Ablation; Reveal XT; LASSO; Atrial Fibrillation monitoring; Ablation Frontiers
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: LAAPITUP