Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)

Atrial Fibrillation Clinical Trial

— ERACE  

Official title:

Evaluate Reduction in Asymptomatic Cerebral Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520532
• Other study ID #: MDT-AFS-ERACE
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: November 2012

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

The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is at least 18 years old

• Subject has been diagnosed with atrial fibrillation (AF)

• Subject is indicated for a pulmonary vein ablation using PVAC

• Subject (or subject's legally authorized representative) is able and and willing to give informed consent.

Exclusion Criteria:

• Subject has permanent AF

• Subject has a left atrial thrombus detected on TEE

• Subject has had a prior left atrial ablation

• Subject has a intracardiac thrombus

• Subject is contraindicated for Warfarin (Coumadin)

• Subject has a cardiac valve prosthesis

• Subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)

• Subject has presence of any pulmonary vein stents

• Subject has presence of any pre-existing pulmonary vein stenosis

• Subject has had a cerebral ischemic event (strokes or transient ischemic attacks [TIA]) which occurred during the 6 month interval preceding the Consent Date

• Subject is a woman known to be pregnant

• Subject is unwilling or unable to comply fully with study procedures and follow-up

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Magnetic Resonance Imaging (MRI)
MRI's will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at the Pre-Discharge will undergo an MRI at the 1 month follow-up visit.

Locations

Country	Name	City	State
Belgium	AZ Middelheim	Antwerpen
Belgium	Imelda Ziekenhuis	Bonheiden
Canada	Southlake Regional Health Center	Newmarket	Ontario
Germany	Herz- und Gefäß-Klinik	Bad Neustadt/Saale
Germany	Praxisklinik - Herz- und Gefässe	Dresden
Italy	Clinica Pineta Grande	Castel Volturno
Netherlands	AZ Sint Antonius Ziekenhuis	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Belgium,  Canada,  Germany,  Italy,  Netherlands, 

References & Publications (1)

Verma A, Debruyne P, Nardi S, Deneke T, DeGreef Y, Spitzer S, Balzer JO, Boersma L; ERACE Investigators. Evaluation and reduction of asymptomatic cerebral embolism in ablation of atrial fibrillation, but high prevalence of chronic silent infarction: resul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.	An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.	Within 1-3 days post ablation
Secondary	Acute Safety Events	Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.	30 days
Secondary	Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.	The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.	Day 1 (End of Procedure)