Clinical trial NCT01095770: Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP
Official title: Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Atrial Fibrillation
Atrial Fibrillation Ablation
Atrial Fibrillation monitoring
Ablation Frontiers
Reveal XT
LASSO
Lead sponsor: Eastbourne General Hospital
Sponsor class: OTHER
First posted: 2010-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: AF Burden
timeFrame: 12 Months
measure: AF Burden
timeFrame: 12 months
measure: AF Burden detected
timeFrame: 12 months
Secondary outcomes:
measure: Arrhythmia frequency - symptomatic or asymptomatic.
timeFrame: 12 months
measure: Time to first episode of AF
timeFrame: 12 months
measure: Average AF duration
timeFrame: 12 months
measure: Time to persistent AF.
timeFrame: 12 months
measure: Average SR duration.
timeFrame: 12 months
Other outcomes:
Locations:
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
state: East Sussex
Study officials:
affiliation: East Sussex NHS Trust
name: Stephen S Furniss, FRCP, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Sussex NHS Trust
name: AN Sulke, FRCP, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.