Class III cardiovascular and structural heart devices, run through European sites with VARC-3 endpoints, imaging core lab, independent adjudication, PMCF and CER.
Chief Operating Officer & Head of Cardiovascular
in cardiac surgery & cardiovascular device evaluation
Head of Cardiovascular Clinical Operations · DACH
ReCor
in international clinical research (cardiovascular & interventional)
Chief Data Officer · Biometrics & Data Systems
in clinical data management, EDC & biometrics systems
Senior Clinical Data Manager · Cardiovascular
in cardiovascular clinical data management
Lead Clinical Project Manager · Cardiovascular programs (France & UK)
in clinical research & medical device studies
Our clinical team on site with the manufacturers who trust Eclevar to run their cardiovascular and structural heart evidence.
| Pillar | Delivery |
|---|---|
| Clinical strategy and study design | Evidence gap assessment, clinical development pathway, protocol and CIP, endpoints, statistical design. |
| Sites and clinical operations | Site and investigator feasibility, start up, monitoring, safety management across European cardiovascular centers. |
| Imaging, adjudication and data | Core lab model, CEC and adjudication charters, EDC, data management, imaging reconciliation. |
| Regulatory evidence and post market integration | Submissions, CER, PMCF, PSUR alignment, Notified Body deficiency response. |
Cardiovascular programs fail on the seams between work packages: a protocol that the biostatistician never stress-tested, endpoints the core lab cannot adjudicate, a CER disconnected from the PMCF plan. Eclevar removes the seams: clinical strategy, study design, data management, biostatistics and submission evidence are built by one team, informed by former Notified Body cardiovascular review experience, bringing reviewer-side insight into evidence planning and submission readiness.
| Where you are | Start here |
|---|---|
| You have a device but no European evidence strategy | Cardiovascular Evidence and Study Strategy Assessment |
| You have a protocol that has not been stress tested | Study design and biostatistics review |
| You need centers that can recruit and contract | Site and investigator feasibility |
| Your endpoints require independent adjudication | Core lab and CEC design |
| Your Notified Body requested more evidence | Deficiency response and evidence remediation |
| You need long term durability evidence | Cardiovascular PMCF program |
The offer that carries the pillar. We assess the evidence your device family needs, the pathway it should follow and the countries, sites, imaging and statistical model that can deliver it, before the first work package is committed. The recommendation is independent and can challenge the current plan.
A mutual CDA can be executed before document exchange, and materials are handled through Eclevar's controlled document sharing process.
Each family carries its own population, endpoints and registry landscape. This section situates them; the owning page carries the full design.
TAVI, mitral, tricuspid, LAAO, occluders. Elderly and frail populations, CT sizing, echo core labs, adjudicated endpoints and multi-year follow-up. Start with the structural heart evidence overview, then the dedicated TAVI page.
Structural Heart Clinical EvidenceStents, drug-coated balloons, guidewires, microcatheters, vascular closure. High-volume procedures with strong comparator expectations and dense procedural data. Evidence hinges on operator effects, lesion complexity and event adjudication.
Coronary Device Clinical EvidencePeripheral intervention, EVAR and TEVAR, embolic protection, grafts. Anatomically diverse populations and long durability horizons; imaging surveillance and reintervention data dominate the plan. Scoped through the strategy assessment; a dedicated page is in preparation.
Cardiovascular software and connected devices (imaging analysis, AI-assisted interpretation, physiological monitoring) follow a different regulatory logic under Rule 11 and are covered by our SaMD and Digital Health cluster, not treated as a cardiovascular family here, to keep evidence requirements and search intent distinct.
Eclevar supports the complete cardiovascular evidence lifecycle, from evidence-gap assessment through CE-marking evidence, PMCF and indication expansion. Each stage carries its own objective, dominant risk and owning service page.
| Stage | Objective | Dominant risk |
|---|---|---|
| First-in-human | Initial safety and feasibility | Population, stopping rules, device iteration |
| Pivotal | Performance and clinical benefit | Endpoints, comparator, sample size |
| PMCF | Confirm safety, performance, durability | Long-term follow-up, loss to follow-up, registry fit |
| CER maintenance | Keep clinical evidence current | Consistency across CER, PMS and labeling |
Owning pages: First-in-Human · Pivotal · PMCF · CER.
This is where a cardiovascular specialist earns its place. Each challenge below carries a concrete consequence a generalist CRO tends to discover too late.
| Challenge | Concrete consequence |
|---|---|
| Rapid device iterations | Weakens the link between the investigated generation and the CE-marked device; design changes, comparability and residual uncertainty must be documented throughout. |
| Small eligible populations and screen failures | Anatomical eligibility drives high screen-failure; enrollment assumptions built on prevalence, not eligibility, break the timeline. |
| Operator and center effects, learning curves | Early cases inflate complication rates; roll-in patients and, where appropriate, CUSUM handling must be designed in, or the pivotal result is confounded. |
| Composite endpoints and event adjudication | Poorly defined or inconsistently adjudicated composite endpoints are a recurring source of review questions; definitions and a CEC charter belong in the CIP. |
| Long-term durability | Valve and implant claims require multi-year follow-up; a study closed at one year cannot support a durability claim the label makes. |
| Study, CER, PMS and PMCF alignment | Divergence between the trial, the CER and the PMCF plan surfaces at audit; they must be one evidence narrative, not four documents. |
The reviewer's-eye view of these deficiencies is set out in MDR Compliance for Class III Cardiac Implants.
Cardiovascular sites are not interchangeable. Recruitment concentrates in high-volume tertiary centers with mature heart-team decision-making and on-site CT, echo and cath-lab capability. Feasibility is less can we find sites than can we win priority at the right ones: investigator relationships and per-center commitments decide timelines, and competing valve trials at any high-volume center must be mapped per site, not per country.
Endpoints depend on the device family; composites must be justified; follow-up duration follows the risk and the claim; and major clinical events often require independent adjudication, particularly in pivotal and high-risk implant studies. Cardiovascular endpoints span mortality, stroke, myocardial infarction, rehospitalisation, device and procedural success, hemodynamic performance, reintervention, functional status and long-term durability. How these are defined and adjudicated, and how VARC-3 structures them from first-in-human to pivotal, is set out in the endpoint reference guide.
Owner: Structural Heart Trials: VARC-3 Endpoints from FIH to Pivotal.
Imaging is often the primary evidence of device performance, so standardization must be designed into the protocol, not retrofitted. Echo, CT, angiography and hemodynamic assessment need defined acquisition, a core-lab charter, qualified readers and imaging-transfer logistics solved before activation, with reads reconciled against the EDC. A core lab or CEC may become necessary when key endpoints depend on blinded, independent assessment.
Owner: Cardiovascular Endpoint Adjudication and Core Lab Services.
From site echo and CT to core lab reads, DICOM pseudonymisation and endpoint adjudication, we keep a single controlled pipeline, so the same clinical event never exists in three inconsistent forms.
The statistical strategy is built with the protocol, the imaging plan, the adjudication plan, the follow-up model and the regulatory claims, never bolted on afterwards.
Owners: Clinical Data Management · Biostatistics · Sample Size · Imaging and Core Lab Data.
Class III cardiac implants are subject to heightened MDR scrutiny and may fall within the Clinical Evaluation Consultation Procedure (CECP) under Article 54. Literature alone is often insufficient to support the full clinical evidence package for novel or high-risk cardiac implants; equivalence is hard to demonstrate for iterating devices; durability and long-term follow-up are scrutinised; and the CER, risk management file, PMS, PMCF and labeling must tell a consistent benefit-risk story. Device-generation traceability, proving which generation the evidence supports, is a recurring pressure point.
Cardiovascular devices need post-market evidence that most other device types do not: multi-year durability, imaging surveillance, reintervention rates and device-deficiency trends in real-world populations. The strategy distinguishes prospective PMCF studies, registry-based PMCF and RWE, and for aortic valve devices, national registries can carry part of the burden. The dedicated page carries the design; registry proper nouns live in the registry directory.
Owner: Post Market Clinical Follow Up. The dedicated cardiovascular PMCF and registry page is in preparation.
Country choice drives timeline, recruitment and cost more than any other single decision. This pillar frames the trade-off and links out; it does not detail any national submission pathway.
| Country | Cardiovascular profile and main operational challenge | Hub |
|---|---|---|
| Germany | Strong network of high volume structural heart centers, established imaging and national registry infrastructure; site contracting and start up are complex. | Germany hub, live |
| France | Strong heart centers plus early funding pathways; convention unique standardises contracting. | France hub, in preparation |
| United Kingdom | Experienced centres and NHS networks; cost attribution and NHS contracting add complexity. | UK hub, in preparation |
| Italy, Spain, Nordics | Additional site networks and registries; backlog hubs, promoted on demand. | on demand |
Structural Heart Clinical Trials in Germany (flagship intersection) · Where Should I Run My Study?.
Clinical strategy, protocol and CIP, regulatory submissions, site feasibility, KOL and investigator network, monitoring, safety management, core lab and adjudication, data management, biostatistics, CER and PMCF are managed as one evidence program rather than disconnected work packages. The advantage is not breadth for its own sake, it is that a decision made in study design is already understood by the statisticians, the data managers and the writers who will defend it at submission.
Heart Team coordination, high-volume structural heart centers, proctoring logistics and monitoring, with VARC-3 endpoints and reimbursement-grade evidence built in from the protocol onwards.
Named, verifiable expertise. Every row carries an exact, substantiable proof.
| Name | Role | Exact proof |
|---|---|---|
| Prof. Mark DaCosta | COO and CMO, Cardiovascular | Cardiac surgeon and former senior cardiovascular reviewer at TÜV SÜD (confirmed, published on eclevarmedtech.com) |
| Pierre-Marie Boutanquoi | Head of Medical Writing | CER and Notified Body deficiency-response experience |
| Sébastien Meier Piantanida | Chief Data Officer, data and biostatistics | Leads data management, biostatistics and the Milo clinical data platform (published on eclevarmedtech.com) |
| Charline Petitdemange | Lead Clinical Project Manager | Site qualification, monitoring and TMF for European investigations under ISO 14155:2020 (published on eclevarmedtech.com) |
| Prof. Georg Nickenig | Scientific advisory board | [confirm public-reference rights, SME] |
Related Eclevar pages across the cardiovascular and structural heart program, from clinical strategy and device evidence to core lab, PMCF and country delivery.
Format: device, evidence challenge, Eclevar intervention, result. These engagements are named because they are already published on the Eclevar client success stories page.
TAVI device portfolio, Class III. Challenge: reimbursement grade clinical evidence satisfying UK NICE requirements and post-Brexit MDR equivalent expectations. Eclevar: design and delivery of a multicentre reimbursement clinical study across leading UK cardiology centers. Result: a running multicentre study built on Eclevar's cardiovascular clinical expertise and site network.
Class III cardiovascular and orthopedic portfolio. Challenge: sustain post market clinical evidence across multiple product lines. Eclevar: PMCF survey strategy across the portfolio, run in parallel with the TAVI study. Result: a portfolio-wide PMCF survey program.
Coronary guidewire portfolio. Challenge: pass Notified Body review of the clinical evidence. Eclevar: clinical evidence preparation and review readiness. Result: Notified Body review completed with zero major nonconformity reports, a verified outcome published by Eclevar.
Global vascular portfolio, Class III. Challenge: bridge Japanese regulatory logic to European Notified Body clinical evidence expectations. Eclevar: clinical evaluation strategy, PMCF architecture and structured deficiency response methodology. Result: an EU MDR market access evidence framework across the portfolio.
Get a structured read on evidence strategy, endpoints, sites and timeline for your device, grounded in what European reviewers and expert panels actually expect.
Request a cardiovascular evidence assessment
