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

Eastbourne General Hospital

Status: Unknown

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: Permanent Dual Chamber Pacemaker; Device: Reveal XT; Procedure: AF Ablation with Ablation Frontiers Technology; Procedure: AF Ablation with LASSO catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01095770

LAAPITUP

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 4 patient groups

Ablation Frontiers Ablation

Active Comparator group

Description:

This group will undergo AF ablation using Ablation Frontiers Technology.

Treatment:

Procedure: AF Ablation with Ablation Frontiers Technology

LASSO ablation

Active Comparator group

Description:

This group will undergo atrial fibrillation ablation with traditional LASSO technology

Treatment:

Procedure: AF Ablation with LASSO catheter

Reveal XT monitoring

Active Comparator group

Description:

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

Treatment:

Device: Reveal XT

Permanent Pacemaker - dual chamber

Active Comparator group

Description:

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

Treatment:

Device: Permanent Dual Chamber Pacemaker