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Completed

NCT Number: NCT01767558

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ZNA Middelheim, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Measure acute procedural success

    Time frame: 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)

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

    Time frame: 0-45 days post-ablation procedure

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2013
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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