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.
Many device studies can adapt an existing design framework. Structural heart programs usually cannot rely on a generic template. Four things converge here that rarely converge elsewhere: a population frequently too high-risk for surgery, endpoints that only carry weight once independently adjudicated, imaging that is itself the primary evidence of device performance, and durability claims that demand multi-year follow-up. A program designed without accounting for all four fails predictably: an enrollment plan built on prevalence rather than anatomical eligibility, a composite endpoint the core lab cannot adjudicate, or a study closed at one year that cannot support the durability the label claims.
The sections below set out these shared challenges in turn. They apply, in different proportions, to every transcatheter valve and occluder device. Only once they are understood does the choice between device families become a design decision rather than a guess.
Structural heart populations are elderly, comorbid and frequently inoperable, the reason the transcatheter approach exists. That shapes every downstream decision.
The country-level reality of this, where these patients concentrate, is covered in the country hubs, not here. See Where Should I Run My Study?.
Structural heart is one of the few device fields with consensus endpoint frameworks, VARC-3 for aortic and evolving equivalents for mitral and tricuspid, and these consensus frameworks are commonly used to structure endpoint selection and adjudication. As a shared territory, three principles hold across every family: endpoints are composites that must be justified, they require independent adjudication to carry weight, and follow-up duration follows the durability claim rather than convenience. Endpoints span mortality, stroke, device and procedural success, hemodynamic performance, reintervention and long-term valve durability.
How VARC-3 defines each endpoint, and how the hierarchy is applied from first-in-human to pivotal, is set out in full in the endpoint reference guide; this page frames why the framework matters as a common thread, not the definitions themselves.
Owner: Structural Heart Trials: VARC-3 Endpoints from FIH to Pivotal (X-03).
European execution
Country selection drives cardiovascular center density, device adoption, registry access, imaging readiness, follow-up reliability, contracting timelines and cost per patient.
Registry access and data governance vary by Nordic country and are assessed individually during feasibility.
In structural heart, imaging is not documentation, it is the primary evidence of device performance. Echo, CT and angiography establish eligibility, guide sizing, and measure the endpoints themselves. That makes standardization a design decision taken before the first site opens, not a retrofit.
The service Eclevar runs operationally, core lab set-up and adjudication, is detailed on its own page. Cardiovascular Endpoint Adjudication and Core Lab Services (SS-CARD-2).
Structural heart studies generate exceptionally dense procedural, imaging and longitudinal datasets: adjudicated procedural CRFs, imaging integration, core-lab reconciliation, device accountability and years of follow-up, all of which must reconcile cleanly at database lock. The statistical strategy is built alongside the protocol, imaging plan and adjudication plan, never afterwards.
Owners: Clinical Data Management · Biostatistics · How Many Patients?.
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.
Two threads run through every structural heart program and rarely through other device types. First, operator and center effects: these are technically demanding implants, so early cases inflate complication rates and the learning curve must be designed in, roll-in patients, proctoring readiness and, where appropriate, CUSUM handling, or the pivotal result is confounded. Second, durability: valve and occluder claims live or die on multi-year follow-up. Structural valve deterioration, reintervention and long-term haemodynamics cannot be evidenced by a study that closes at one year, so the follow-up model is set by the claim the label will make.
Most structural heart implants fall within Class III and are subject to heightened MDR scrutiny, frequently including the Clinical Evaluation Consultation Procedure (CECP) under Article 54. As a shared territory, the expectations are consistent: literature alone is often insufficient for novel high-risk implants, equivalence is hard to demonstrate for iterating devices, durability is scrutinised, and the CER, risk file, PMS and PMCF must tell one benefit-risk story. Device-generation traceability, proving which generation the evidence supports, is a recurring pressure point across the whole field.
Structural heart programs often require unusually intensive post-market evidence, including multi-year durability, imaging surveillance, reintervention tracking and device-deficiency trends in real-world populations. The strategy distinguishes prospective PMCF studies, registry-based PMCF and RWE. For some device types, an existing national registry can carry part of the burden where it is fit for purpose and captures the relevant device, population, endpoints and follow-up; where registry coverage is thinner, targeted PMCF studies fill the gap, a genuine differentiator by family, developed on each family page.
The registry landscape by specialty (national arthroplasty and valve registries) is catalogued separately.
Everything above is shared. What follows is where the families diverge, each with a few lines on what makes it different, then a link to its own page for the full design.
Transcatheter aortic valve. The most established family: VARC-3 endpoints, CT-driven sizing, echo core lab, and GARY as post-market infrastructure. Distinguished by mature comparator data and the deepest durability evidence base.
TAVI Clinical StudiesTranscatheter mitral repair and replacement. Distinguished by MVARC endpoints, mitral-regurgitation grading, a heart-failure population rather than a stenotic one, and the near-impossibility of sham control, driving reliance on blinded echo assessment.
Mitral valve trials, page in preparationTranscatheter tricuspid intervention. Distinguished by TVARC endpoints, an emerging evidence base with fewer precedents, and functional and quality-of-life endpoints carrying more weight than in aortic disease.
Tricuspid valve trials, page in preparationLeft-atrial-appendage occluders. Distinguished by an atrial-fibrillation population, stroke-prevention and bleeding endpoints rather than hemodynamic ones, thin registry coverage, and single-arm designs with objective performance criteria.
LAAO clinical evidence, page in preparationASD, PFO, PVL and structural defects. Distinguished by younger and more varied populations, defect-specific endpoints, and shorter durability horizons than valve devices.
Structural occluder evidence, page in preparationHeart 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.
Country selection depends on center volume, imaging readiness, referral pathways, contracts and long-term follow-up capability. This page frames the principle; the country axis owns the execution detail.
Related Eclevar pages across the cardiovascular and structural heart program, from clinical strategy and device evidence to core lab, PMCF and country delivery.
Structural heart evidence is built by people who have seen it from both the operating theatre and the reviewer's desk.
Scientific advisory board, including Prof. Georg Nickenig. [confirm public-reference rights before go-live] Structural heart delivery record: [anonymised program count / references to add]
Get a structured read on population, endpoints, imaging strategy and follow-up for your device, grounded in what structural heart reviewers and expert panels expect.
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