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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01767558
• Other study ID #: PRECISION GOLD
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Ablation Catheter (PVAC) GOLD.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hungary,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-45 days post-ablation procedure
Secondary	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)	0-1 days after procedure
Secondary	Report procedure and/or device related serious adverse events using PVAC GOLD		0-45 days post-ablation procedure