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Dataset results
229 results for “Implantable devices”
Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review - Dataset
<p><strong>Background: </strong>The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.</p> <p><strong>Methods: </strong>Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes.</p> <p><strong>Results: </strong>Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations.</p> <p><strong>Conclusion: </strong>European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.</p>
SIMCor - Demo of fast-to-evaluate surrogate models used for device implantation
<p>This video illustrates a fast to evaluate model for TAVI device implantation based on isogeometric analysis. The tissue is modelled in a rigid manner, meaning that no deformation can be caused by the device. The device deployment is modelled using an expanding cylinder and assessing the contacts between device and tissue. This approach allows rapid evaluation of the risk of paravalvular leakage for different device orientations.</p>
Safety of Magnetic Resonance Imaging With Patients Who Have Mixed Lead Cardiac Implantable Electronic Devices
ClinicalTrials.gov study NCT07155135. IPD Sharing: NO. Countries: 1. Publications: 12.
Influence of Cardiac Implantable Electronic Devices on the Hemostatic System
ClinicalTrials.gov study NCT04499612. IPD Sharing: UNDECIDED. Countries: 1. Publications: 1.
Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners.
ClinicalTrials.gov study NCT07040176. IPD Sharing: YES. Countries: 1. Publications: 4.
Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
ClinicalTrials.gov study NCT01369706. IPD Sharing: Not stated. Countries: 2. Publications: 1.
Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.
ClinicalTrials.gov study NCT02809131. IPD Sharing: NO. Countries: 1. Publications: 1.
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
ClinicalTrials.gov study NCT02554903. IPD Sharing: UNDECIDED. Countries: 1. Publications: 1.
Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study
ClinicalTrials.gov study NCT04146883. IPD Sharing: NO. Countries: 1. Publications: 6.
Phosphodiesterase-5-inhibitors for Right Heart Failure After Left Ventricular Assist Device Implantation
ClinicalTrials.gov study NCT04117659. IPD Sharing: NO. Countries: 1. Publications: 7.
Fasting Versus Non-Fasting for Cardiac Implantable Electronic Devices (FastCIED Study)
ClinicalTrials.gov study NCT04389697. IPD Sharing: Not stated. Countries: 1. Publications: 1.
PECs for Implantable Cardiac Electronic Device Insertion
ClinicalTrials.gov study NCT05528627. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
ClinicalTrials.gov study NCT06914570. IPD Sharing: YES. Countries: 1. Publications: 7.
SWITCH: Stentrode First-in-Human Study of Implantable BCI for Control of a Digital Device
ClinicalTrials.gov study NCT03834857. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation Study
ClinicalTrials.gov study NCT03775759. IPD Sharing: NO. Countries: 1. Publications: 1.
Reduction Or Elimination Of Radiation During Implantation of Cardiac Devices Using Ultrasound
ClinicalTrials.gov study NCT04858698. IPD Sharing: NO. Countries: 1. Publications: 1.
Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
ClinicalTrials.gov study NCT00199602. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Treatment of Mild to Moderate Peri-implantitis Using an Oscillating Chitosan Device
ClinicalTrials.gov study NCT03373448. IPD Sharing: NO. Countries: 2. Publications: 1.
Remote Programming of Cardiac Implantable Electronic Device
ClinicalTrials.gov study NCT05366660. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
ClinicalTrials.gov study NCT02559011. IPD Sharing: Not stated. Countries: 1. Publications: 13.
ScienceDex guides
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