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

Purpose

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	Intervention
Paroxysmal Atrial Fibrillation	Procedure: AF Ablation with Ablation Frontiers Technology Procedure: AF Ablation with LASSO catheter Device: Reveal XT Device: Permanent Dual Chamber Pacemaker


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Genetic and Rare Diseases Information Center resources: Familial Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Eastbourne General Hospital:

Primary Outcome Measures:

AF Burden [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Time to persistent AF (atrial fibrillation episode lasting for 7 days)
Average SR duration. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	50
Study Start Date:	April 2010
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	16 Years to 80 Years (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095770

Contacts


Contact: Steven J Podd, MBBS, MRCP, BA	01323 417400 ext 4132	steven.podd@esht.nhs.uk

Locations


United Kingdom
Eastbourne District General Hospital	Not yet recruiting
Eastbourne, East Sussex, United Kingdom, BN21 2UD
Contact: Steven J Podd, MBBS, MA, MRCP 01323 417400 ext 4132 steven.podd@esht.nhs.uk
Sub-Investigator: Steven J Podd, MBBS, MA, MRCP

Sponsors and Collaborators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Dr AN Sulke, East Sussex NHS Trust
ClinicalTrials.gov Identifier:	NCT01095770 History of Changes
Other Study ID Numbers:	LAAPITUP
Study First Received:	March 29, 2010
Last Updated:	March 29, 2010
Health Authority:	United Kingdom: National Health Service United Kingdom: Research Ethics Committee

Keywords provided by Eastbourne General Hospital:


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

Additional relevant MeSH terms:


Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes

ClinicalTrials.gov processed this record on September 26, 2016

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