Paroxysmal Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Atrial Fibrillation Ablation, Atrial Fibrillation monitoring, Ablation Frontiers, Reveal XT, LASSO
Brief 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.
Interventions
PROCEDUREAF Ablation with Ablation Frontiers Technology
AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.
PROCEDUREAF Ablation with LASSO catheter
AF Ablation with traditional LASSO catheter
DEVICEReveal XT
Reveal XT implantable loop recorder monitored group
DEVICEPermanent Dual Chamber Pacemaker
This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.
Sponsors
Eastbourne General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AF Burden detected | 12 months | To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter. |
| AF Burden | 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average AF duration | 12 months | Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes. |
| Arrhythmia frequency - symptomatic or asymptomatic. | 12 months | 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. |
| Average SR duration. | 12 months | 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. |
| Time to persistent AF. | 12 months | Time to persistent AF (atrial fibrillation episode lasting for 7 days) |
| Time to first episode of AF | 12 months | Time to persistent AF is defined as the time from ablation to the first recorded episode of AF |
Countries
United Kingdom
Contacts
Primary ContactSteven J Podd, MBBS, MRCP, BA
Outcome results
None listed