Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC)
NCT ID: NCT01520532
Last Updated: 2018-10-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2012-03-31
2012-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety of Cardiac Pacemakers in 1.5T Tesla MRI
NCT00336011
MRI Assessment of Arrythmia Ablation Lesions
NCT02761343
Evaluating PVI Using CMR
NCT05437549
Study Evaluating the Use of MRI on CMS Patients
NCT02513056
Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device.
NCT00798512
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ablation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yves De Greef, MD
Role: PRINCIPAL_INVESTIGATOR
AZ Middelheim
Lucas Boersma, MD
Role: PRINCIPAL_INVESTIGATOR
AZ Sint Antonius Ziekenhuis
Thomas Deneke, MD
Role: PRINCIPAL_INVESTIGATOR
Krankenhaus Porz am Rheim
Stefano Nardi, MD
Role: PRINCIPAL_INVESTIGATOR
Pineta Grande Hospital
Atul Verma, MD
Role: PRINCIPAL_INVESTIGATOR
Southlake Regional health Center
Stefan G Spitzer, MD
Role: PRINCIPAL_INVESTIGATOR
Praxisklinik Herz- und Gefässe
Philippe Debruyne, MD
Role: PRINCIPAL_INVESTIGATOR
Imelda Hospital, Bonheiden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AZ Middelheim
Antwerp, , Belgium
Imelda Ziekenhuis
Bonheiden, , Belgium
Southlake Regional Health Center
Newmarket, Ontario, Canada
Herz- und Gefäß-Klinik
Bad Neustadt/Saale, , Germany
Praxisklinik - Herz- und Gefässe
Dresden, , Germany
Clinica Pineta Grande
Castel Volturno, , Italy
AZ Sint Antonius Ziekenhuis
Nieuwegein, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MDT-AFS-ERACE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.