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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01767558
First received: January 8, 2013
Last updated: June 6, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Other: Ablation / MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD

Resource links provided by NLM:


Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:
  • Measure rate of post-procedure asymptomatic cerebral embolic (ACE) as determined by MRI [ Time Frame: 1-45 days post-ablation procedure ] [ Designated as safety issue: No ]
    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:
  • Measure acute procedural success [ Time Frame: 0-1 days after procedure ] [ Designated as safety issue: No ]

    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)

  • Report procedure and/or device related serious adverse events using PVAC GOLD [ Time Frame: 0-45 days post-ablation procedure ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other: 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.


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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767558

Locations
Belgium
ZNA Middelheim
Antwerpen, Belgium
France
Hopital Cardiolgique du Haut-Leveque
Pessac, France
Germany
Zentraklinik Bad Berka
Bad Berka, Germany
St. Agnes Hospital Bocholt
Bocholt, Germany
Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR
Dresden, Germany
Hungary
Debrecen University
Debrecen, Hungary
Netherlands
Catharina Hospital
Eindhoven, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
United Kingdom
Eastbourne District General Hospital
Eastbourne, United Kingdom
University Hospital of South Manchester
Manchester, United Kingdom
Freeman Hospital
Newcastle Upon Tyne, United Kingdom
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
  More Information

No publications provided

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01767558     History of Changes
Other Study ID Numbers: PRECISION GOLD
Study First Received: January 8, 2013
Last Updated: June 6, 2014
Health Authority: Belgium: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
Netherlands: Independent Ethics Committee
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014