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 · from TAVI valves to vascular devices.
TAVI has one of the most mature evidence bases among transcatheter valve technologies, and that maturity sets the bar high.
A comparator evidence base exists, VARC-3 is commonly used to structure endpoint selection and adjudication in contemporary TAVI studies, and reviewers are familiar with the recurring weaknesses of TAVI programs. Three things shape every TAVI study: an elderly, comorbid population whose eligibility turns on precise CT anatomy; endpoints (paravalvular leak, new pacemaker, stroke) that are device-defining, where major safety and effectiveness endpoints often require independent adjudication; and durability claims that demand follow-up measured in years, not months. This page translates the shared structural heart challenges into concrete TAVI design decisions.
For the challenges TAVI shares with every transcatheter device, see Structural Heart Clinical Evidence.
Population, comparator and endpoints all follow from the indication.
Remains the principal indication in most TAVI clinical programs; risk stratum defines the comparator (surgery vs medical management vs another valve).
Failed surgical or transcatheter bioprostheses; distinct anatomy, sizing and hemodynamic considerations.
High, intermediate and lower-risk populations, each with different comparator expectations and endpoint sensitivity.
Expansion toward lower-risk and younger populations, where durability and comparator expectations become more demanding; bicuspid anatomy and asymptomatic disease raise further evidence-generation questions.
TAVI eligibility depends heavily on CT anatomy, in addition to disease severity, surgical risk and heart-team assessment, which is why screen-failure planning built on prevalence breaks the timeline.
A TAVI program is a sequence, each stage with its own objective and dominant risk.
| Stage | Objective | Dominant TAVI-specific risk |
|---|---|---|
| First-in-human / EFS | Initial safety and feasibility | Sizing accuracy, access, learning curve |
| Pilot | Refine technique and endpoints | PVL, pacemaker rates, roll-in effects |
| Pivotal | Performance and benefit vs comparator | Comparator choice, non-inferiority margin |
| PMCF | Confirm real-world safety and durability | Long-term follow-up, SVD, reintervention |
Stage owners: First-in-Human · Pivotal · PMCF.
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.
TAVI endpoints follow the VARC-3 framework; this section maps which ones drive a TAVI program and why, not how each is defined.
| TAVI endpoint | Why it drives the program |
|---|---|
| Device and procedural success | Correct positioning, function and absence of procedural complications, the primary efficacy signal. |
| All-cause and CV mortality | Time-to-event, adjudicated; competing-risk methods for the frail population. |
| Stroke (disabling / non-disabling) | Device-defining safety endpoint; requires neurological adjudication. |
| New permanent pacemaker | Conduction disturbance is TAVI-specific and valve-design-sensitive, particularly for technologies with different radial force, implantation depth or interaction with the conduction system. |
| Paravalvular leak (PVL) | Residual PVL remains an important safety and performance signal, with severity assessed by core-lab echocardiography. |
| Haemodynamics and valve performance | Gradients, effective orifice area, echo core-lab read across follow-up. |
| Rehospitalisation and QoL | Valve-related rehospitalisation and functional status matter in an elderly cohort. |
| Structural valve deterioration (SVD) | The durability endpoint, only evidenced by multi-year follow-up. |
Definitions and hierarchy: Structural Heart Trials: VARC-3 Endpoints from FIH to Pivotal.
The follow-up model is set by the durability claim. Illustrative schedule, adapted to indication, study phase, claims and regulatory commitments.
| Timepoint | Primary purpose |
|---|---|
| Procedure / discharge | Device and procedural success, acute complications |
| 30 days | Early safety: stroke, pacemaker, PVL, mortality |
| 6 months / 1 year | Primary efficacy, haemodynamics, functional status |
| 2 years | Sustained performance, early durability signals |
| 5 years and beyond | Structural valve deterioration, reintervention, long-term survival |
In TAVI, imaging establishes eligibility, guides sizing and measures the endpoints. Standardization is designed in before activation.
The core-lab service Eclevar operates (set-up, blinded reads, reconciliation) is detailed on its own page. Cardiovascular Endpoint Adjudication and Core Lab Services.
A Clinical Events Committee (CEC) should be considered during CIP development when primary or major safety endpoints require independent adjudication. TAVI's defining events are adjudicated against pre-specified definitions.
The adjudication service is covered by SS-CARD-2; this section frames the TAVI-specific need.
TAVI generates dense, multi-source data that must reconcile at database lock: procedural CRFs (device, sizing, access), imaging integration and core-lab reconciliation, device accountability, concomitant medication, rehospitalisation capture, adjudication datasets, and years of longitudinal follow-up.
Owner: Clinical Data Management, delivered on the MILO EDC platform.
The design choice follows the indication and comparator, built with the imaging and adjudication plans.
Owners: 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.
TAVI is technically demanding and valve-specific, so the learning curve is a design variable, not an afterthought. Early cases may show higher complication rates while operators and centers move through the learning curve, PVL and vascular events especially, so roll-in patients, proctoring readiness, site-volume criteria and, where appropriate, CUSUM handling must be built into the protocol, or the pivotal result is confounded by operator experience rather than device performance.
TAVI valves are Class III implantables under heightened MDR scrutiny, and may fall within the CECP under Article 54 depending on the applicable regulatory pathway and exemptions. TAVI-specific expectations: device-specific clinical data (literature and equivalence rarely suffice for a novel valve), durability evidence proportionate to the claim, device-generation traceability across iterating valve designs, and a CER, PMS and PMCF that tell one benefit-risk story.
TAVI PMCF is durability-driven and runs for years: prospective PMCF studies, registry-based PMCF, imaging surveillance for structural valve deterioration, reintervention tracking and long-term safety. For aortic valve devices specifically, a fit-for-purpose national registry, such as GARY in Germany, may support part of the durability-surveillance burden where it captures the relevant device, population and follow-up.
PMCF and Post-Market Clinical Follow-UpThe country axis owns the detail.
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 clinical oversight, former Notified Body review experience, core lab, CEC, data management and biostatistics, delivered in one TAVI workflow.
Scientific advisory board, including Prof. Georg Nickenig. [confirm public-reference rights before go-live] TAVI delivery record: [anonymised program count / references to add]
Related Eclevar pages across the cardiovascular and structural heart program, from clinical strategy and device evidence to core lab, PMCF and country delivery.
Get a structured read on population, CT screening strategy, endpoints, core lab, sample size and durability follow-up for your valve, grounded in what TAVI reviewers and expert panels expect.
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