Structural Heart and Coronary Trial Feasibility in Europe: What It Takes

From Opportunity to Operational Reality

In practice, feasibility begins with a realistic understanding of where eligible patients are located across individual healthcare systems. Referral pathways, local treatment standards, and competing studies all influence whether theoretical patient pools translate into actual recruitment.

For structural heart trials in particular, patient identification is often more nuanced than anticipated. Multidisciplinary heart teams, imaging gatekeeping, and evolving treatment guidelines can significantly shape inclusion rates. A site that performs a high volume of procedures does not automatically mean it will enroll efficiently in a clinical trial.

Regulatory and Start-Up Timelines: Planning Beyond Averages

The European regulatory framework demands careful planning at each country level. Local ethics committees, competent authorities, and, where applicable, radiation or data protection bodies must all be navigated. Timelines can vary widely, not only between countries, but sometimes between regions within the same country.

Feasibility, therefore, requires:

• Country-specific regulatory intelligence
• Realistic start-up projections based on recent experience
• Alignment of submission strategies across jurisdictions

Underestimating these timelines is one of the most common pitfalls. What appears feasible on paper can quickly become delayed if regulatory sequencing and documentation requirements are not fully anticipated.

Site Selection: Precision Over Volume

A successful feasibility strategy prioritizes fit over fame. While leading centers bring visibility and expertise, they are often managing multiple competing trials and complex clinical workloads. Site selection must balance reputation with availability, motivation, and operational readiness.

Key considerations include:

• Dedicated research infrastructure, staffing, and operational reliability
• Prior performance in similar device trials
• Investigator engagement beyond initial interest
• Realistic assessment of competing studies
• Regulatory readiness
• Real-world patient access
• Cultural and language barriers
• Patient data and documentation quality in line with MDR expectations

In coronary trials, where patient flow may be higher, the challenge often lies in identifying sites that can consistently screen and randomize within tight timelines. In structural heart trials, procedural complexity and patient selection criteria make investigator commitment even more critical.

Cardiac Imaging and Endpoint Strategy: Start Early in Feasibility

Imaging is not a downstream consideration, it is central to feasibility. Protocol requirements for echocardiography, CT, and angiography must align with site capabilities from the outset. Differences in imaging equipment, acquisition protocols, and local expertise can introduce variability if not addressed early.

Feasibility assessments should therefore include:

• Detailed imaging capability questionnaires
• Early engagement with core laboratories
• Clear definitions of acquisition and transfer requirements

This ensures that endpoints are not only measurable, but consistently interpretable across all participating sites.

Early Parallelization: Contracts, Budgets, and Hidden Timelines

Even when regulatory approvals are secured, study activation depends heavily on contract and budget negotiations. In Europe, these processes are often decentralized and can vary significantly between institutions.

Common challenges include:

• Prolonged contract negotiations at hospital or university level
• Variability in per-patient costs and overhead structures
• Alignment of payment terms with local expectations
• Incomplete and inconsistent site documentation

A robust feasibility assessment accounts for these factors upfront, incorporating realistic timelines for site activation, not just approval.

Patient Access and Retention: Beyond Enrollment

Recruitment is only one part of the equation. Structural heart and coronary trials frequently require long-term follow-up, sometimes extending over several years. Feasibility must therefore consider patient retention, follow-up visit compliance, and the ability of sites to maintain engagement over time.

Healthcare system structure plays a role here. Countries with centralized care pathways may facilitate follow-up, while more fragmented systems may require additional coordination and patient management strategies.

The Role of Local Expertise in European Trials

Executing a multi-country European trial requires more than central oversight, it is a cultural, regulatory, and operational challenge. Local expertise, whether through regional teams or in-country partners, is essential to navigate language, regulatory nuance, and institutional dynamics.

Feasibility is strengthened when insights are grounded in:

• Recent, country-specific operational experience
• Established relationships with sites and investigators
• Practical understanding of how processes function beyond written guidelines

From Insight to Impact: Turning Feasibility Into Execution

A thorough feasibility process does more than validate a study, it shapes it. Inclusion criteria may be refined, country selection adjusted, timelines recalibrated, and operational strategies optimized based on what is realistically achievable.

In structural heart and coronary trials, where complexity is inherent and expectations are high, this level of rigor is not optional. It is the difference between a study that progresses predictably and one that encounters avoidable delays.

Europe offers exceptional potential, but realizing that potential depends on understanding the details beneath the surface. Feasibility, when done properly, is where that understanding begins, and where successful trials are ultimately defined.

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