--- title: "Your CRO for Cardiology Medical Devices | QbD Group" description: "As a European CRO dedicated to medical devices, we offer deep expertise in Cardiology Medical Device clinical research. From heart failure devices and sten" url: https://qbdgroup.com/en/industries/medical-devices/md-cro-cardiology type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"Your CRO for Cardiology Medical Devices | QbD Group\", https://qbdgroup.com/en/industries/medical-devices/md-cro-cardiology" --- # Your CRO for Cardiology Medical Devices Specialized support for clinical research in cardiology As a European CRO dedicated to medical devices, we offer deep expertise in Cardiology Medical Device clinical research. From heart failure devices and stents to structural heart innovations, we support your journey from strategy to post-market follow-up. At QbD Clinical, we know your priority is delivering innovative **cardiology medical devices** to patients, safely and efficiently. That's why we don't just run clinical trials; we collaborate with you to drive results. As a European CRO dedicated exclusively to medical devices, we offer deep expertise in **Cardiology Medical Device clinical research**. From heart failure devices and stents to structural heart innovations and cardiovascular diagnostics, we support your journey from strategy to post-market follow-up. We help you navigate complexity, accelerate timelines, and ensure **MDR and ISO 14155 compliance**, so you can move your cardiology innovations forward with confidence. Client Cases ## Cardiology Client Cases ### Vascular | SaMD - Indication Coronary Artery Disease / SaMD - Study type Post-Market Registry / Dynamic Coronary Roadmap Monitoring / 5 Years - Sites 4 Sites / Middle-East | Europe | US - Subjects 394 Subjects - Services Project Oversight, Monitoring, Site Management, Local Resources ### Cardio | Heart Failure - Indication Ischemic Heart Diseases / In-heart Microcomputer - Study type First-In-Human / Study in Close-Out - Sites 12 Sites / Europe | Middle-East - Subjects 45 Subjects - Services Regulatory Submissions, Project Management, Monitoring, Medical Writing, MDR Consulting ### Cardio | Structural Heart - Indication Aortic Valve Disease / Ultrasound Therapy Equipment - Study type Pivotal / 1 Year FUP - Sites 11 Sites / Europe - Subjects 60 Subjects - Services Full CRO Services, Regulatory Submissions, Biostatistics, Safety & Data Management, Core Lab, CEC & DSMB ### Cardio | Arrhythmia - Indication Atrial Fibrillation / Left Atrial Appendage Exclusion - Study type Post-Market / Study in Enrolment - Sites Up to 24 Sites / Europe | Asia-Pac - Subjects Up to 6500 Subjects Forecasted (globally) - Services Regulatory Submissions, Site Management, Monitoring, OUS Oversight, Rescue Project Medical Advisory Board ## Meet the Medical Advisory Board Our Medical Advisory Board brings together experienced life sciences professionals who provide expert guidance on clinical strategy, patient safety, scientific rigor, and regulatory compliance. ### Pierfrancesco Agostoni Interventional Cardiologist - 20+ years of experience in invasive and interventional cardiology - Performs 300–400 complex PCIs and approximately 80 TAVI procedures per year - Expert in CTO interventions, radial access, and advanced percutaneous techniques - 310+ PubMed-indexed publications and 10+ book chapters ### Gijs Klarenbeek Physician & Clinical Development Expert - Medical doctor with training in general surgery - Extensive experience in clinical development and regulatory approval of medical devices - Therapeutic expertise in cardiovascular, respiratory, oncology, diabetes, and more Areas of expertise ### QbD Clinical's Independent Medical Advisory Board - Strategic & scientific advice - Clinical study support - • Input study design/protocol - • Act as independent Medical Monitor - • Act as CEC/DSMB member - Clinical evidence support - • Clinical Development planning - • Support Risk assessment - • Validate clinical relevance - Therapeutic training for QbD Group employees Case studies ## Featured CRO Case Studies We bring hands-on expertise to complex cardiovascular studies, from first-in-human trials to global post-market programs. Heart Failure ### Heart Failure Study, First-In-Human Device - Supported a first-in-human clinical study for an in-heart microcomputer treating ischemic heart disease. - Managed 12 sites across Europe and the Middle East, involving 45 enrolled subjects. - Delivered end-to-end clinical support: regulatory submissions, project and site management, monitoring, and medical writing. - Provided MDR compliance consulting throughout the trial lifecycle. Structural Heart ### Structural Heart Study, Pivotal Trial in EU - Oversaw a pivotal study for an ultrasound therapy device targeting aortic valve disease. - Managed 11 sites across Europe, enrolling 60 subjects with one-year follow-up. - Delivered full-service CRO support, including regulatory submissions, biostatistics, safety and data management, and core lab coordination. - Facilitated CEC and DSMB oversight to ensure robust clinical governance. Arrhythmia ### Post-Market Study, Arrhythmia Device - Supporting a large-scale post-market study for a device treating atrial fibrillation and left atrial appendage exclusion. - Coordinating up to 24 sites across Europe and Asia-Pacific, with a global forecast of 6,500+ subjects. - Stepped in as a rescue CRO, taking over monitoring, site management, and regulatory submissions mid-study. - Ensuring smooth OUS oversight and operational continuity across regions. Vascular ### Vascular SaMD, Post-Market Registry - Managed a five-year post-market registry for a coronary artery disease SaMD. - Operated across 4 sites in the Middle East, Europe, and the US, enrolling 394 subjects. - Provided local resource coordination, site management, and ongoing project oversight. - Supported dynamic coronary roadmap monitoring and long-term safety tracking. Resources ## Related Resources Explore practical guidance, assessments, and insights for cardiology device trials in Europe. Self-Assessment ### EU Readiness Assessment for Cardiology Trials Check your trial readiness across MDR, ISO 14155, and European site requirements. [Read more](https://qbdgroup.com/en/eu-readiness-cardiology) Blog ### First Structural Heart Trial in Europe Key considerations when running your first structural heart device study in the European market. [Read more](https://qbdgroup.com/en/blog/first-structural-heart-trial-europe) Blog ### Structural Heart & Coronary Trial Pitfalls in Europe Avoid the most common operational and regulatory mistakes in cardiovascular trials. [Read more](https://qbdgroup.com/en/blog/structural-heart-coronary-trial-pitfalls-europe) Blog ### Structural Heart & Coronary Trial Feasibility in Europe How to assess site feasibility, patient pathways, and evidence requirements before you start. [Read more](https://qbdgroup.com/en/blog/structural-heart-coronary-trial-feasibility-europe) Blog ### Cardiac Device Trials in Europe: MDR Strategy A practical guide to aligning your cardiac device trial strategy with EU MDR expectations. [Read more](https://qbdgroup.com/en/blog/cardiac-device-trials-europe-mdr-strategy) ## Plan your clinical pathway From gap assessment to full CRO delivery, our clinical experts are ready to support your MedTech journey. Contact us --- Source: https://qbdgroup.com/en/industries/medical-devices/md-cro-cardiology — © QbD Group. Quote freely with attribution and a link back.