Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP (LAAPITUP)
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|ClinicalTrials.gov Identifier: NCT01095770|
Recruitment Status : Unknown
Verified March 2010 by Eastbourne General Hospital.
Recruitment status was: Not yet recruiting
First Posted : March 30, 2010
Last Update Posted : March 30, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation||Procedure: AF Ablation with Ablation Frontiers Technology Procedure: AF Ablation with LASSO catheter Device: Reveal XT Device: Permanent Dual Chamber Pacemaker||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||November 2012|
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.
- AF Burden [ Time Frame: 12 Months ]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 [ Time Frame: 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 [ Time Frame: 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.
- Arrhythmia frequency - symptomatic or asymptomatic. [ Time Frame: 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 [ Time Frame: 12 months ]Time to persistent AF is defined as the time from ablation to the first recorded episode of AF
- Average AF duration [ Time Frame: 12 months ]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 Frame: 12 months ]Time to persistent AF (atrial fibrillation episode lasting for 7 days)
- Average SR duration. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095770
|Contact: Steven J Podd, MBBS, MRCP, BA||01323 417400 ext email@example.com|
|Eastbourne District General Hospital|
|Eastbourne, East Sussex, United Kingdom, BN21 2UD|
|Contact: Steven J Podd, MBBS, MA, MRCP 01323 417400 ext 4132 firstname.lastname@example.org|
|Sub-Investigator: Steven J Podd, MBBS, MA, MRCP|
|Principal Investigator:||Stephen S Furniss, FRCP, MD||East Sussex NHS Trust|
|Principal Investigator:||AN Sulke, FRCP, MD||East Sussex NHS Trust|