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

NCT01095770 | Unknown

• 1 other identifier: LAAPITUP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is 3 fold:-

1. 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. 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. 3.To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Arrhythmia frequency - symptomatic or asymptomatic.

  12 months

• Time to first episode of AF

  12 months

• Average AF duration

  12 months

• Time to persistent AF.

  12 months

• Average SR duration.

  12 months

Study Arms (4)

Ablation Frontiers Ablation

ACTIVE COMPARATOR

This group will undergo AF ablation using Ablation Frontiers Technology.

Procedure: AF Ablation with Ablation Frontiers Technology

LASSO ablation

ACTIVE COMPARATOR

This group will undergo atrial fibrillation ablation with traditional LASSO technology

Procedure: AF Ablation with LASSO catheter

Reveal XT monitoring

ACTIVE COMPARATOR

This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder.

Device: Reveal XT

Permanent Pacemaker - dual chamber

ACTIVE COMPARATOR

This group will be monitored pre and post ablation with a dual chamber permanent pacemaker

Device: Permanent Dual Chamber Pacemaker

Interventions

AF Ablation with Ablation Frontiers Technology PROCEDURE

AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.

Ablation Frontiers Ablation

AF Ablation with LASSO catheter PROCEDURE

AF Ablation with traditional LASSO catheter

LASSO ablation

Reveal XT DEVICE

Reveal XT implantable loop recorder monitored group

Reveal XT monitoring

Permanent Dual Chamber Pacemaker DEVICE

This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.

Permanent Pacemaker - dual chamber

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eastbourne General Hospital: lead

Study Sites (1)

Eastbourne District General Hospital

Eastbourne, East Sussex, BN21 2UD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26310300 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen S Furniss, FRCP, MD

  East Sussex NHS Trust

  PRINCIPAL INVESTIGATOR

• AN Sulke, FRCP, MD

  East Sussex NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven J Podd, MBBS, MRCP, BA

CONTACT

01323 417400; steven.podd@esht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 30, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 30, 2010

Record last verified: 2010-03

Locations

GB (1)