Clinical trial NCT01520532: Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
Official title: Evaluate Reduction in Asymptomatic Cerebral Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years old
* Subject has been diagnosed with atrial fibrillation (AF)
* Subject is indicated for a pulmonary vein ablation using PVAC
* Subject (or subject's legally authorized representative) is able and and willing to give informed consent.

Exclusion Criteria:

* Subject has permanent AF
* Subject has a left atrial thrombus detected on TEE
* Subject has had a prior left atrial ablation
* Subject has a intracardiac thrombus
* Subject is contraindicated for Warfarin (Coumadin)
* Subject has a cardiac valve prosthesis
* Subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
* Subject has presence of any pulmonary vein stents
* Subject has presence of any pre-existing pulmonary vein stenosis
* Subject has had a cerebral ischemic event (strokes or transient ischemic attacks \[TIA\]) which occurred during the 6 month interval preceding the Consent Date
* Subject is a woman known to be pregnant
* Subject is unwilling or unable to comply fully with study procedures and follow-up

Primary outcomes:
measure: New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.
timeFrame: Within 1-3 days post ablation
Secondary outcomes:
measure: Acute Safety Events
timeFrame: 30 days
measure: Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.
timeFrame: Day 1 (End of Procedure)
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: AZ Middelheim
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Newmarket
country: Canada
facility: Southlake Regional Health Center
state: Ontario
city: Bad Neustadt/Saale
country: Germany
facility: Herz- und Gefäß-Klinik
city: Dresden
country: Germany
facility: Praxisklinik - Herz- und Gefässe
city: Castel Volturno
country: Italy
facility: Clinica Pineta Grande
city: Nieuwegein
country: Netherlands
facility: AZ Sint Antonius Ziekenhuis
Study officials:
affiliation: AZ Middelheim
name: Yves De Greef, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Sint Antonius Ziekenhuis
name: Lucas Boersma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Krankenhaus Porz am Rheim
name: Thomas Deneke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pineta Grande Hospital
name: Stefano Nardi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southlake Regional health Center
name: Atul Verma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Praxisklinik Herz- und Gefässe
name: Stefan G Spitzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imelda Hospital, Bonheiden
name: Philippe Debruyne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verma A, Debruyne P, Nardi S, Deneke T, DeGreef Y, Spitzer S, Balzer JO, Boersma L; ERACE Investigators. Evaluation and reduction of asymptomatic cerebral embolism in ablation of atrial fibrillation, but high prevalence of chronic silent infarction: results of the evaluation of reduction of asymptomatic cerebral embolism trial. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):835-42. doi: 10.1161/CIRCEP.113.000612. Epub 2013 Aug 27.