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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Eastbourne General Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Eastbourne General Hospital
ClinicalTrials.gov Identifier:
NCT01095770
First received: March 29, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.

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:


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
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

No publications provided

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 16, 2014