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

Not Applicable

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: AF Ablation with Ablation Frontiers Technology; Procedure: AF Ablation with LASSO catheter; Device: Reveal XT; Device: Permanent Dual Chamber Pacemaker

• Registration Number: NCT01095770
• Lead Sponsor: Eastbourne General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-29
• Last Update Submitted: 2010-03-29
• Study First Posted: 2010-03-30
• Last Update Posted: 2010-03-30
• Study Start: 2010-04
• Primary Completion: 2012-04
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ablation Frontiers Ablation	AF Ablation with Ablation Frontiers Technology	This group will undergo AF ablation using Ablation Frontiers Technology.
LASSO ablation	AF Ablation with LASSO catheter	This group will undergo atrial fibrillation ablation with traditional LASSO technology
Reveal XT monitoring	Reveal XT	This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder.
Permanent Pacemaker - dual chamber	Permanent Dual Chamber Pacemaker	This group will be monitored pre and post ablation with a dual chamber permanent pacemaker

Primary Outcome Measures

Name	Time	Method
AF Burden	12 months	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	12 months	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

Name	Time	Method
Time to persistent AF.	12 months	Time to persistent AF (atrial fibrillation episode lasting for 7 days)
Arrhythmia frequency - symptomatic or asymptomatic.	12 months	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	12 months	Time to persistent AF is defined as the time from ablation to the first recorded episode of AF
Average AF duration	12 months	Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes.
Average SR duration.	12 months	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.

Trial Locations

Locations (1)

Eastbourne District General Hospital; 🇬🇧 Eastbourne, East Sussex, United Kingdom