PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)

Medtronic

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: Ablation / MRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01767558

PRECISION GOLD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

Ablation / MRI

Other group

Description:

All subjects will undergo a standard of care ablation procedure for paroxysmal AF with the CE-Marked PVAC GOLD catheter. MRIs will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at Pre-Discharge will undergo another MRI at the 1 month follow-up visit.

Treatment:

Other: Ablation / MRI