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

NCT01767558 | Completed

• 1 other identifier: PRECISION GOLD
• Study Type: interventional
• Target: 56
• Locations: 6 countries
• Sites: 11

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Measure rate of post-procedure asymptomatic cerebral embolic (ACE) as determined by MRI

  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.

  1-45 days post-ablation procedure

Secondary Outcomes (2)

• Measure acute procedural success

  0-1 days after procedure

• Report procedure and/or device related serious adverse events using PVAC GOLD

  0-45 days post-ablation procedure

Study Arms (1)

Ablation / MRI

OTHER

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.

Other: Ablation / MRI

Interventions

Ablation / MRI OTHER

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.

Ablation / MRI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (11)

ZNA Middelheim

Antwerp, Belgium

Location

Hopital Cardiolgique du Haut-Leveque

Pessac, France

Location

Zentraklinik Bad Berka

Bad Berka, Germany

Location

St. Agnes Hospital Bocholt

Bocholt, Germany

Location

Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR

Dresden, Germany

Location

Debrecen University

Debrecen, Hungary

Location

Catharina Hospital

Eindhoven, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Eastbourne District General Hospital

Eastbourne, United Kingdom

Location

University Hospital of South Manchester

Manchester, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26826134 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 14, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 19, 2018

Record last verified: 2018-09

Locations

FR (1); HU (1); BE (1); DE (3); NL (2); GB (3)