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

September 17, 2018 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-45 days post-ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0-1 days after procedure
Report procedure and/or device related serious adverse events using PVAC GOLD
Time Frame: 0-45 days post-ablation procedure
0-45 days post-ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 14, 2013

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECISION GOLD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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