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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ablation / MRI
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ZNA Middelheim
  • Hopital Cardiolgique du Haut-Leveque
  • Zentraklinik Bad Berka
  • St. Agnes Hospital Bocholt
  • Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR
  • Debrecen University
  • Catharina Hospital
  • St. Antonius Hospital
  • Eastbourne District General Hospital
  • University Hospital of South Manchester
  • Freeman Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ablation / MRI

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Measure acute procedural success
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

Full Information

First Posted
January 8, 2013
Last Updated
September 17, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01767558
Brief Title
PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)
Official Title
Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ablation / MRI
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ablation / MRI
Intervention Description
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 Measure Information:
Title
Measure rate of post-procedure asymptomatic cerebral embolic (ACE) as determined by MRI
Description
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.
Time Frame
1-45 days post-ablation procedure
Secondary Outcome Measure Information:
Title
Measure acute procedural success
Description
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)
Time Frame
0-1 days after procedure
Title
Report procedure and/or device related serious adverse events using PVAC GOLD
Time Frame
0-45 days post-ablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
ZNA Middelheim
City
Antwerpen
Country
Belgium
Facility Name
Hopital Cardiolgique du Haut-Leveque
City
Pessac
Country
France
Facility Name
Zentraklinik Bad Berka
City
Bad Berka
Country
Germany
Facility Name
St. Agnes Hospital Bocholt
City
Bocholt
Country
Germany
Facility Name
Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR
City
Dresden
Country
Germany
Facility Name
Debrecen University
City
Debrecen
Country
Hungary
Facility Name
Catharina Hospital
City
Eindhoven
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands
Facility Name
Eastbourne District General Hospital
City
Eastbourne
Country
United Kingdom
Facility Name
University Hospital of South Manchester
City
Manchester
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26826134
Citation
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.
Results Reference
derived

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

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