Atrial FibrillationNCT01767558
PRECISION GOLD Post Market Study in Europe of Pulmonary Vein Ablation Catheter (PVAC GOLD)
A study testing Ablation / MRI in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 11 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ablation / MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 11 sitesin 6 countries
- Study dates
- Jan 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
Germany3 sites
Zentraklinik Bad Berka
Bad Berka
St. Agnes Hospital Bocholt
Bocholt
Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR
Dresden
United Kingdom3 sites
Eastbourne District General Hospital
Eastbourne
University Hospital of South Manchester
Manchester
Freeman Hospital
Newcastle upon Tyne
Netherlands2 sites
Catharina Hospital
Eindhoven
St. Antonius Hospital
Nieuwegein
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation / MRI
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation / MRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ablation / MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-45 days post-ablation procedure
Secondary outcomes (2)
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)
Measured: 0-1 days after procedure
Report procedure and/or device related serious adverse events using PVAC GOLD
Measured: 0-45 days post-ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767558
- Sponsor's protocol ID
- PRECISION GOLD
- Status last verified
- Sep 2018
- First submitted
- 8 Jan 2013
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26826134
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD
- ClinicalTrials.gov ID
- NCT01767558
- Acronym / sponsor ID
- PRECISION GOLD
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation / MRI | Other | Other: Ablation / MRIAll 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ablation / MRIAll 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 |
Primary outcome
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.
2 secondary outcomes
Measure acute procedural success
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Derived from this study: PubMed 26826134De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation / MRI in people with Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 11 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, United Kingdom, Netherlands, Belgium, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure rate of post-procedure asymptomatic cerebral embolic (ACE) as determined by MRI (time frame: 1-45 days post-ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01767558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.