Clinical trial NCT01767558: PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)
Official title: Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2013-01-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe. The purpose of the study is to evaluate asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.

Detailed description: 10-12 centers in Europe will enroll up to 56 subjects who meet the inclusion/exclusion criteria and provide consent to participate in the study. Subjects will undergo an ablation for paroxysmal AF with the Medtronic PVAC GOLD (CE-Mark). To assess for ACE lesions, pre- and post-ablation procedure cerebral MRIs will be done along with a neurological exam (Mini Mental State Exam). Subjects will be followed for 1 month post-procedure when a repeat MRI and neurological exam will be conducted if the subject had a positive MRI at pre-hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Symptomatic AF (\>/=2 recurrent AF episodes that self terminate or AF \</=48 hours that are cardioverted)
* Documentation of \>/=1 paroxysmal AF events within past year
* AF symptoms (e.g. palpitations, fatigue, exertional dyspnea, effort intolerance)
* Prescribed to vitamin K antagonist (e.g. warfarin/coumadin)
* Age 18-70 years old
* Clinically indicated for a pulmonary vein ablation
* Willing and able to give informed consent
* Willing, able and committed to participate in all study required activities for the duration of the study

Exclusion Criteria:

* Diagnosis of persistent or permanent AF
* Prior left atrial ablation
* Presence of intracardiac thrombus
* Contraindicated for vitamin K antagonist
* Prescribed to direct thrombin or factor inhibitors (e.g. dabigatran, rivaroxaban)
* Prescribed to any investigational drug that may confound the study results
* Cardiac valve prosthesis
* Significant congenital heart defect (corrected or not)
* Pulmonary vein stents
* Pre-existing pulmonary vein stenosis
* Cerebral ischemic event (e.g. stroke, TIA) that occurred within 6 months of study consent date
* If female - pregnancy
* Participation in any other cardiovascular clinical study
* Contraindicated for MRI
* Active sepsis
* Blood clotting abnormalities (genetic)
* Presence of left atrial myxoma
* Venous filtering device (e.g. Greenfield filter)
* Invasive cardiac procedure in past 90 days

Primary outcomes:
measure: Measure rate of post-procedure asymptomatic cerebral embolic (ACE) as determined by MRI
timeFrame: 1-45 days post-ablation procedure
Secondary outcomes:
measure: Measure acute procedural success
timeFrame: 0-1 days after procedure
measure: Report procedure and/or device related serious adverse events using PVAC GOLD
timeFrame: 0-45 days post-ablation procedure
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Pessac
country: France
facility: Hopital Cardiolgique du Haut-Leveque
city: Bad Berka
country: Germany
facility: Zentraklinik Bad Berka
city: Bocholt
country: Germany
facility: St. Agnes Hospital Bocholt
city: Dresden
country: Germany
facility: Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR
city: Debrecen
country: Hungary
facility: Debrecen University
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
References:
citation: De Greef Y, Dekker L, Boersma L, Murray S, Wieczorek M, Spitzer SG, Davidson N, Furniss S, Hocini M, Geller JC, Csanadi Z; PRECISION GOLD investigators. Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial. Europace. 2016 May;18(5):687-95. doi: 10.1093/europace/euv385. Epub 2016 Jan 29.