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

Paroxysmal Atrial Fibrillation Clinical Trial

— LAAPITUP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01095770
• Other study ID #: LAAPITUP
• Status: Not yet recruiting
• Phase: N/A
• First received: March 29, 2010
• Last updated: March 29, 2010
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: March 2010
• Source: Eastbourne General Hospital
• Contact: Steven J Podd, MBBS, MRCP, BA
• Phone: 01323 417400
• Email: steven.podd[@]esht.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• AF Ablation with Ablation Frontiers Technology
AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.
• AF Ablation with LASSO catheter
AF Ablation with traditional LASSO catheter

Device:
• Reveal XT
Reveal XT implantable loop recorder monitored group
• Permanent Dual Chamber Pacemaker
This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.

Locations

Country	Name	City	State
United Kingdom	Eastbourne District General Hospital	Eastbourne	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Eastbourne General Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Arrhythmia frequency - symptomatic or asymptomatic.	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.	12 months	No
Secondary	Time to first episode of AF	Time to persistent AF is defined as the time from ablation to the first recorded episode of AF	12 months	No
Secondary	Average AF duration	Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes.	12 months	No
Secondary	Time to persistent AF.	Time to persistent AF (atrial fibrillation episode lasting for 7 days)	12 months	No
Secondary	Average SR duration.	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.	12 months	No