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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Ablation / MRI

• Registration Number: NCT01767558
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ablation / MRI	Ablation / MRI	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.

Primary Outcome Measures

Name	Time	Method
Measure rate of post-procedure asymptomatic cerebral embolic (ACE) as determined by MRI	1-45 days post-ablation procedure	Pre- and post-ablation MRIs will be evaluated for ACE lesions. If the post-ablation MRI (within 16-72 hours) is positive for ACE, a repeat MRI will be completed at the 1 month visit.

Secondary Outcome Measures

Name	Time	Method
Report procedure and/or device related serious adverse events using PVAC GOLD	0-45 days post-ablation procedure
Measure acute procedural success	0-1 days after procedure	Acute procedural success is defined as: * Only PVAC GOLD catheters used to achieve pulmonary vein (PV) isolation; * All accessible PVs were isolated (entrance block); * Sinus rhythm is restored at the end of the ablation procedure (with or without cardioversion)

Trial Locations

Locations (11)

Zentraklinik Bad Berka; 🇩🇪 Bad Berka, Germany

Debrecen University; 🇭🇺 Debrecen, Hungary

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

Catharina Hospital; 🇳🇱 Eindhoven, Netherlands

Hopital Cardiolgique du Haut-Leveque; 🇫🇷 Pessac, France

Eastbourne District General Hospital; 🇬🇧 Eastbourne, United Kingdom

St. Agnes Hospital Bocholt; 🇩🇪 Bocholt, Germany

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

University Hospital of South Manchester; 🇬🇧 Manchester, United Kingdom

Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR; 🇩🇪 Dresden, Germany

Freeman Hospital; 🇬🇧 Newcastle Upon Tyne, United Kingdom