TAVI · Structural heart · EU MDR
Transcatheter aortic valve implantation is a class III implant, and its evidence bar is the highest the MDR sets. We run structural heart investigations to VARC-3, with an independent clinical events committee, an imaging core lab and Heart Team eligibility built in from the protocol.
Structural heart
666-patient TAVI programme, UK
A multicentre transcatheter aortic valve investigation run for Meril across UK sites, under ISO 14155.
Cardiovascular leadership
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
Awards, funding, accountability
The MILO Health platform received the Platinum Award through the xShare Open Call, organised by EUCROF and co-funded by the European Union. Amsterdam, 2 February 2026.
The announcement →Horizon Europe Grant Agreement 101136734. Eclevar contributes to the European Health Data Space work on clinical research data quality.
xShare results →Eclevar MedTech and the MILO clinical platform are backed by private investors and venture capital, including Ballas Invest.
Funding & investors →Trusted by global manufacturers
What this page covers
01 · The regulatory frame
A transcatheter heart valve is a class III implantable device. It sits at the top of the MDR classification, so the depth of clinical evidence, and the rigour of the investigation that produces it, is not negotiable.
Article 62 / Article 70
A pre-market clinical investigation conducted to demonstrate conformity is governed by Article 62 of Regulation (EU) 2017/745, which sets the general requirements: ethical approval, informed consent, a justified design and a benefit-risk assessment against the state of the art. The application and authorisation route runs through the Member State under Article 70. For a structural heart device, both are read by reviewers who have seen every shortcut, so the protocol is written to ISO 14155:2026 good clinical practice from the first draft.
What a class III valve investigation must carry
ISO 14155:2026
ISO 14155 is the good clinical practice standard for clinical investigations of medical devices in human subjects. It governs the responsibilities of sponsor and investigator, risk management integration with ISO 14971, monitoring, and the handling of adverse device effects. Every Eclevar structural heart investigation is built to it, so the trial that supports your CE mark also stands up as an evidence source in the clinical evaluation report.
02 · The endpoint language
The Valve Academic Research Consortium 3 definitions, published in 2021, are the accepted framework for aortic valve clinical research. Using them makes your results comparable to the trials a Notified Body and a payer already know.
Successful access, delivery and deployment, correct position, intended performance and freedom from surgery or re-intervention related to the device.
A 30-day composite: all-cause mortality, stroke, VARC-3 bleeding, major vascular or cardiac structural complication, acute kidney injury and re-intervention.
A time-related composite beyond 30 days: mortality, stroke, hospitalisation for valve disease or heart failure, and prosthetic valve dysfunction.
Mean gradient, effective orifice area and paravalvular regurgitation, graded to a standard scale and read centrally.
VARC-3 standardises bleeding severity, access-site and non-access-site vascular complications, and new conduction disturbance including permanent pacemaker implantation. These are the events where transcatheter valves most often differ, and where a consistent definition changes the interpretation of a whole trial.
03 · Independence and central reading
Endpoints only mean something if they are judged the same way for every patient, by people with no stake in the result. Two independent structures do that work.
An independent clinical events committee adjudicates every primary endpoint against the pre-specified VARC-3 definitions, blinded to device allocation where the design allows. A data safety monitoring board oversees patient safety through the study and can recommend changes or a stop. Neither the sponsor nor the sites decide whether an event counts.
An independent imaging core lab performs standardised CT annulus sizing before the procedure, reads transthoracic (TTE) and transoesophageal (TEE) echocardiography at each follow-up, and grades paravalvular regurgitation and gradients to a single scale. Central reading removes site-to-site variability from the haemodynamic endpoints that carry a valve's performance argument.
Why independence is not optional for a class III valve
Proof, not adjectives
04 · The right patient
Who receives a transcatheter valve is not a single clinician's call. It is a multidisciplinary decision, and in a clinical investigation that decision has to be recorded, not assumed.
The multidisciplinary decision
Eligibility for TAVI is decided by a Heart Team: in practice an interventional cardiologist, a cardiac surgeon and an imaging specialist, who together review the anatomy, surgical risk and comorbidity of each candidate. In a clinical investigation that decision is documented against the protocol inclusion and exclusion criteria, which protects the integrity of the enrolled population and the interpretability of the endpoints. A population that drifts from the protocol is the fastest way to weaken an otherwise strong study.
What the Heart Team assessment protects
Talk to a reviewer
Book a structural heart readiness review with a cardiac surgeon and former Notified Body reviewer. We tell you whether your endpoints, adjudication and imaging plan will hold, and what is missing.
Book a readiness review
05 · Service
Structural heart clinical evidence services for medical device manufacturers in France, Germany, the United Kingdom, Ireland, Switzerland, Italy, Spain and the Netherlands.
Protocol, endpoints and statistical plan for a class III valve, built to ISO 14155:2026 and MDR Article 62, with VARC-3 endpoints pre-specified.
The clinical investigation application and authorisation route through the Member State, with the essential documents a competent authority expects.
Device success, early safety, clinical efficacy and haemodynamic endpoints defined to VARC-3, so results map to the published trial base.
An independent CEC and a data safety monitoring board, charters written, events adjudicated blinded to allocation where the design allows.
Central CT annulus sizing and TTE/TEE echocardiography reading, with standardised grading of gradients and paravalvular regurgitation.
Eligibility captured against inclusion and exclusion criteria, so the enrolled population matches the intended-use claim.
Endpoint capture in MILO Studio, 21 CFR Part 11 compliant, with in-house biometry, monitoring across our European network and a single database lock.
PMCF studies and registry follow-up for long-term valve durability, endpoints defined to VARC-3 so pre and post-market data reconcile.
The investigation outcomes assembled into the CER for cardiovascular devices, under MEDDEV 2.7/1 Rev 4 and EU MDR.
Endpoints, imaging data and resource use are captured in MILO Studio, so the structural heart investigation, its adjudication and its follow-up run on a single audit-trailed database. See our cardiovascular clinical strategy under EU MDR →
06 · Proof in practice
The clearest proof that we can run a structural heart investigation is that we have. A multicentre transcatheter aortic valve programme, run for a global valve manufacturer, across UK sites.
A multicentre transcatheter aortic valve implantation investigation across UK sites, run under ISO 14155, feeding the clinical evidence a CER and reimbursement dossier rely on. Exactly the structural heart setting where independent adjudication and central imaging decide whether the data is usable.
Resolution of Notified Body deficiencies, followed by the PMCF and clinical strategy. The same discipline that carries a cardiovascular device through review after the certificate is issued. See client success stories →
PMCF · Multi-country · 5 EU countries
A post-market clinical follow-up programme of 160 patients across 14 leading clinical sites in five countries, run to schedule on the MILO Studio platform. The same multi-country delivery capability a structural heart follow-up depends on.
"Eclevar, with its tailor-made approach and advanced MILO Studio platform, represents a major strategic asset."Antoine Turzi, CEO, RegenLab
07 · After the certificate
A transcatheter valve is implanted for years. The evidence obligation does not end at the CE mark, it extends across the whole implant lifetime.
Annex XIV Part B
Under EU MDR Annex XIV Part B, post-market clinical follow-up is mandatory for a class III implantable device, and for a heart valve the questions it answers are specific: long-term durability, structural valve deterioration, and freedom from re-intervention. We design prospective PMCF studies with follow-up endpoints defined to VARC-3, so the post-market data speaks the same language as the pre-market investigation. Why PMCF is crucial under EU MDR →
Registries & real-world evidence
Where a suitable registry exists, real-world evidence is an efficient route to long-term safety and performance data. We use national and European heart valve registries with follow-up endpoints mapped to the investigation, so registry data supports the CER rather than sitting beside it unreconciled. Real-world evidence and registries →
08 · The evidence, assembled
A clinical investigation that cannot be used in the CER is a wasted study. We design the trial so its outputs become CER inputs without translation.
VARC-3 outcomes are mapped to the general safety and performance requirements the CER has to demonstrate.
The adjudicated VARC-3 dataset and central imaging reads become the clinical data inputs to the CER.
The benefit-risk analysis in the investigation carries straight into the CER conclusion.
Follow-up endpoints feed the CER update cycle across the device lifetime.
This is the point of running the whole programme with one CRO: the clinical evaluation report for cardiovascular devices is not a document assembled at the end from other people's work. It is the destination the investigation was designed to reach, which is why the endpoints, the adjudication and the imaging plan are fixed before the first patient is enrolled.
A cardiac surgeon, former Notified Body reviewers and a biometry team, named, not handed to a junior account team. Meet the full leadership team →
Official Eclevar resources
A whitepaper co-signed by BSI and Eclevar on the clinical requirements of EU MDR.
Read the whitepaper →Questions we hear first
Sources
Structural heart trials in France rely on Heart Team coordination and high-volume cardiac centres. We support TAVI and structural heart sponsors with access to French investigator sites, proctoring logistics and imaging core-lab alignment, under ISO 14155:2026 and EU MDR 2017/745.
On the access side, we build the CNEDiMTS / HAS evidence in parallel with the MDR clinical file, so a TAVI programme addresses both CE marking and French reimbursement in one coordinated plan.
We will tell you whether your TAVI investigation can carry a class III valve through the MDR, what is missing, and how to fix it before the first patient is enrolled.
Book a structural heart readiness review