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

NCT01520532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-10-16

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Yves De Greef, MD · AZ Middelheim

  • Lucas Boersma, MD · AZ Sint Antonius Ziekenhuis

  • Thomas Deneke, MD · Krankenhaus Porz am Rheim

  • Stefano Nardi, MD · Pineta Grande Hospital

  • Atul Verma, MD · Southlake Regional health Center

  • Stefan G Spitzer, MD · Praxisklinik Herz- und Gefässe

  • Philippe Debruyne, MD · Imelda Hospital, Bonheiden

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Belgium
  • Canada
  • Germany
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01520532 on ClinicalTrials.gov