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

NCT01520532 | Completed Results

• 1 other identifier: MDT-AFS-ERACE
• Study Type: interventional
• Target: 60
• Locations: 5 countries
• Sites: 7

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acute Safety Events

  30 days

• Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.

  Day 1 (End of Procedure)

Study Arms (1)

Ablation

OTHER

Other: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI) OTHER

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.

Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (7)

AZ Middelheim

Antwerp, Belgium

Location

Imelda Ziekenhuis

Bonheiden, Belgium

Location

Southlake Regional Health Center

Newmarket, Ontario, L3Y 2P9, Canada

Location

Herz- und Gefäß-Klinik

Bad Neustadt/Saale, Germany

Location

Praxisklinik - Herz- und Gefässe

Dresden, Germany

Location

Clinica Pineta Grande

Castel Volturno, Italy

Location

AZ Sint Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Related 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: results of the evaluation of reduction of asymptomatic cerebral embolism trial. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):835-42. doi: 10.1161/CIRCEP.113.000612. Epub 2013 Aug 27.

  PMID: 23983245 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Jay Kelley, Director of Clinical Research
• Organization: Medtronic AF Solutions

jay.l.kelley@medtronic.com

+1.760.827.0076

Study Officials

• Yves De Greef, MD

  AZ Middelheim

  PRINCIPAL INVESTIGATOR

• Lucas Boersma, MD

  AZ Sint Antonius Ziekenhuis

  PRINCIPAL INVESTIGATOR

• Thomas Deneke, MD

  Krankenhaus Porz am Rheim

  PRINCIPAL INVESTIGATOR

• Stefano Nardi, MD

  Pineta Grande Hospital

  PRINCIPAL INVESTIGATOR

• Atul Verma, MD

  Southlake Regional health Center

  PRINCIPAL INVESTIGATOR

• Stefan G Spitzer, MD

  Praxisklinik Herz- und Gefässe

  PRINCIPAL INVESTIGATOR

• Philippe Debruyne, MD

  Imelda Hospital, Bonheiden

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: January 30, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 16, 2018
• Results First Posted: March 14, 2013

Record last verified: 2018-09

Locations

NL (1); DE (2); BE (2); CA (1); IT (1)