Trial record 20 of 1027 for:
"Embolism and Thrombosis"
Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC) (ERACE)
This study has been completed.
Sponsor:
Medtronic Atrial Fibrillation Solutions
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01520532
First received: January 25, 2012
Last updated: February 12, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation |
Other: Magnetic Resonance Imaging (MRI) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Evaluate Reduction in Asymptomatic Cerebral Embolism |
Resource links provided by NLM:
Further study details as provided by Medtronic Atrial Fibrillation Solutions:
Primary Outcome Measures:
- New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI. [ Time Frame: Within 1-3 days post ablation ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Acute Safety Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.
- Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject. [ Time Frame: Day 1 (End of Procedure) ] [ Designated as safety issue: No ]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.
| Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Ablation |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520532
Locations
| Belgium | |
| AZ Middelheim | |
| Antwerpen, Belgium | |
| Imelda Ziekenhuis | |
| Bonheiden, Belgium | |
| Canada, Ontario | |
| Southlake Regional Health Center | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Germany | |
| Herz- und Gefäß-Klinik | |
| Bad Neustadt/Saale, Germany | |
| Praxisklinik - Herz- und Gefässe | |
| Dresden, Germany | |
| Italy | |
| Clinica Pineta Grande | |
| Castel Volturno, Italy | |
| Netherlands | |
| AZ Sint Antonius Ziekenhuis | |
| Nieuwegein, Netherlands | |
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Investigators
| Principal Investigator: | 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 Ziekenhuis, Bonheiden |
More Information
No publications provided
| Responsible Party: | Medtronic Atrial Fibrillation Solutions |
| ClinicalTrials.gov Identifier: | NCT01520532 History of Changes |
| Other Study ID Numbers: | MDT-AFS-ERACE |
| Study First Received: | January 25, 2012 |
| Results First Received: | December 10, 2012 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Intracranial Embolism and Thrombosis Embolism and Thrombosis Atrial Fibrillation Intracranial Embolism Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Thromboembolism Thrombosis |
ClinicalTrials.gov processed this record on June 17, 2013