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.
Identify the unresolved clinical questions and define the evidence model required to close them.
Design the study, endpoints and data source that can actually close the gap.
Activate sites and retain interpretable follow-up over the full study duration.
Turn clean longitudinal data into CER-ready regulatory evidence.
Cardiovascular PMCF fails when it is treated as a regulatory formality rather than a targeted evidence program. Five failure points break the evidence chain.
| Failure point | Consequence |
|---|---|
| Unclear PMCF question | The study cannot close the evidence gap |
| Registry not fit for purpose | The data cannot support the intended conclusion |
| Weak device traceability | Device generations become mixed |
| Follow-up too short | Durability remains unresolved |
| No CER integration | The study produces data, not regulatory evidence |
The assessment maps intended purpose, claims, studied population, residual risks and Notified Body commitments into a single deliverable, the Eclevar cardiovascular PMCF gap matrix. Three representative gaps:
| Evidence gap | Why it matters | Best data source | Output |
|---|---|---|---|
| Durability | Long-term benefit-risk | Prospective or registry | CER, PSUR |
| Rare safety signal | Safety | Pooled registry or PMCF | PSUR |
| New device generation | Traceability | Prospective cohort | CER |
Other gaps assessed include broader-risk populations, imaging deficiencies, operator variability, missing variants and label-expansion questions.
Not sure which PMCF model your device needs? Request a PMCF gap assessment
The model follows the gap, never the reverse. Each model is delivered end to end: strategy, protocol, sites or network, data, statistics and CER integration.
Best used when: Structured, adjudicated evidence is required
Strength: Control and endpoint robustness
Limitation: Cost and duration
Best used when: Routine use and broader populations matter
Strength: Real-world relevance
Limitation: Less control over practice variation
Best used when: Longitudinal real-world data already exist
Strength: Scale and long-term follow-up
Limitation: Only usable when device, endpoints and data quality are fit for purpose
Best used when: Historical signal or feasibility must be assessed
Strength: Speed and low burden
Limitation: Data quality and completeness limits
Best used when: Use-pattern and experience data are the gap
Strength: Reach across users
Limitation: Rarely sufficient alone
Best used when: Several gaps cannot be resolved by one study
Strength: One integrated evidence plan
Limitation: Requires strong data-source coordination
A hybrid program is often the most appropriate route when several evidence gaps coexist and no single data source can close them.
The four most discriminating criteria in practice:
| Criterion | Acceptable | Gap | Action |
|---|---|---|---|
| Device generation | Exact UDI or model | Family only | Add sponsor dataset |
| Endpoints | Aligned definitions | Partially aligned | Mapping or adjudication |
| Follow-up | Multi-year | Short | Extension |
| Data quality | Audited | Uncertain | Validation |
The decision is not registry versus study. It is which combination provides sufficient control, scale and longitudinal depth for the unresolved evidence question.
Already have access to a registry? Request a registry fit-for-purpose review
Country selection turns on cardiovascular center density, device adoption, registry access, imaging readiness, long-term follow-up reliability, contracting timelines and cost per patient.
Registry access and data governance vary by Nordic country and are assessed individually during feasibility.
Need realistic sites, timelines and costs? Request a European feasibility assessment
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.
End-to-end operational delivery: submissions and notifications where required, contracting and budgets, site activation, monitoring, patient retention and safety management.
Safety and device-deficiency integration. PMCF captures SAEs, device deficiencies, reinterventions, urgent safety measures and PSUR trends, but PMCF does not replace vigilance. The two systems must reconcile, device deficiencies must be traceable, and trends must feed the PSUR and benefit-risk. German-specific safety reporting stays on the dedicated German PMCF compliance page.
Execution service: Cardiovascular Endpoint Adjudication and Core Lab Services. Endpoint taxonomy: VARC-3 endpoints for aortic valve trials.
What makes cardiovascular PMCF data hard: several years of data, change of center, device-version change, historical plus prospective sources, reinterventions outside the center, cause of death, missing imaging and registry linkage.
Delivered on the MILO EDC and ePRO platform where applicable.
| PMCF finding | CER | PSUR | RMF | Next evidence action |
|---|---|---|---|---|
| Stable performance | Confirm | Trend | Maintain | Continue |
| Unexpected event | Reassess | Signal | Update | Investigation |
| Durability decline | Revise | Escalate | New risk | Focused PMCF |
A broader-population benefit is handled separately: it can support a formal indication-extension strategy, subject to the applicable regulatory route and evidence requirements.
Facing a Notified Body PMCF deficiency? Submit the deficiency for review
Eclevar orchestrates the full program and states honestly which functions it leads directly and which specialist functions it coordinates where required.
This split is stated so sponsors know exactly which functions Eclevar controls directly.
Commercial models: strategy and setup fee, per-site setup, per-patient and per-visit costs, registry access or data fee, imaging, core-lab and adjudication packages, annual evidence update.
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.
Cardiac surgeon-led strategy (Dr Mark DaCosta, cardiac surgeon and former TÜV SÜD cardiovascular reviewer) and former Notified Body review experience.
European sites, KOL feasibility and long-term follow-up delivery, with integrated data management.
PMCF Plan to study execution, PMCF Evaluation Report, CER update, PSUR and benefit-risk integration.
EDC, ePRO, registry mapping and imaging integration with longitudinal patient tracking.
Challenge: Limited post-market safety and use-pattern evidence
Model: Multi-country PMCF survey and prospective collection
Delivered: Study design, HCP network, EDC, analysis and CER-ready outputs
Challenge: Durability and late-event uncertainty
Model: Prospective long-term follow-up with imaging
Delivered: Protocol, imaging strategy, adjudication and longitudinal analysis
Challenge: Existing registry insufficient for regulatory use
Model: Fit-for-purpose assessment plus targeted substudy
Delivered: Data mapping, gap closure and regulatory dataset
All cases anonymised.
For sponsors uncertain about the required evidence model. Output: gap matrix and recommended model.
For sponsors needing the protocol, PMCF Plan and SAP. Output: design and feasibility package.
For end-to-end study execution and evidence integration, start-up through the final evidence package. Primary offer
For existing registries that do not fully close the evidence gap. Output: fit assessment and gap-closure program.
Related Eclevar pages across the cardiovascular and structural heart program, from clinical strategy and device evidence to core lab, PMCF and country delivery.
Receive a mapped evidence-gap assessment covering data source, endpoints, follow-up and CER and PSUR integration.
Request a cardiovascular PMCF assessment
