Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP
- Conditions
- Paroxysmal Atrial Fibrillation
- Registration Number
- NCT01095770
- Lead Sponsor
- Eastbourne General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method AF Burden 12 months 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 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.
- Secondary Outcome Measures
Name Time Method 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.
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
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.
Time to persistent AF. 12 months Time to persistent AF (atrial fibrillation episode lasting for 7 days)
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.
Trial Locations
- Locations (1)
Eastbourne District General Hospital
🇬🇧Eastbourne, East Sussex, United Kingdom
Eastbourne District General Hospital🇬🇧Eastbourne, East Sussex, United KingdomSteven J Podd, MBBS, MA, MRCPSub Investigator