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 FailureHeart 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 HeartStructural 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.
ArrhythmiaPost-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.
VascularVascular 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.
EU Readiness Assessment for Cardiology Trials
Check your trial readiness across MDR, ISO 14155, and European site requirements.
Read more
First Structural Heart Trial in Europe
Key considerations when running your first structural heart device study in the European market.
Read more
Structural Heart & Coronary Trial Pitfalls in Europe
Avoid the most common operational and regulatory mistakes in cardiovascular trials.
Read more
Structural Heart & Coronary Trial Feasibility in Europe
How to assess site feasibility, patient pathways, and evidence requirements before you start.
Read more
Cardiac Device Trials in Europe: MDR Strategy
A practical guide to aligning your cardiac device trial strategy with EU MDR expectations.
Read more
Plan your clinical pathway
From gap assessment to full CRO delivery, our clinical experts are ready to support your MedTech journey.