Early-phase cardiovascular device trials in an ASC instead of an academic hospital: where the startup time goes

Cardiovascular device sponsors rarely lose time because a physician says no. They lose it in the months between "yes, we want this study" and the first procedure. In a large academic hospital, that gap is filled with budget reviews, contract redlines, committee calendars and a cath lab schedule that was full before the protocol arrived.

I'm Julio Martinez-Clark, CEO of Amavita Research. We run cardiovascular trials in Miami with investigators who practice inside Amavita Heart and Vascular Health®, and we conduct early-phase work at our affiliated cardiovascular ambulatory surgery center in Kendall. This article explains when a dedicated ASC research setting beats a tertiary hospital for early-phase device work, and when it doesn't.

The short answer

For daytime interventional and outpatient cardiovascular protocols, an ASC-based research site can usually start faster than an academic hospital because fewer organizations sit between the sponsor and the first procedure. The trade-off is scope. An ASC is built for patients who do not need hospital admission, so protocols that require overnight observation or inpatient care belong in a hospital.

The academic hospital startup bottleneck

Academic medical centers are where much of cardiovascular research was built, and for complex inpatient protocols they remain the right choice. For early-phase device work that can be done in a day, their structure adds time that has nothing to do with the science:

• Layered review. Scientific review, conflict-of-interest review, radiation safety, budget approval and IRB review often run in sequence, each on its own meeting calendar.
• Contracting queues. Research administration offices negotiate agreements for many sponsors at once. A first-time device company is rarely at the front of the line.
• Procedure room competition. The cath lab serves emergencies, scheduled clinical cases and several research protocols. A research case gets the slot that is left.
• Staff turnover. Coordinators and research nurses rotate across studies, and each change means retraining on your protocol.

Sponsors routinely tell us they budgeted a few months for academic site startup and spent most of a year. None of that is anyone's fault. It is the cost of sharing a large institution.

What a dedicated ASC research setting looks like

Federal rules define an ambulatory surgical center as a facility that provides surgical services to patients who do not require hospitalization, where the expected duration of services does not exceed 24 hours after admission (42 CFR 416.2). That definition sets both the strength and the limit of the model.

Our Phase 1 and early-phase work runs at Advanced Cardiovascular of Miami, an affiliated, licensed, Medicare-certified and AAAHC-accredited cardiovascular ambulatory surgery center in Kendall. What sponsors get there:

• Procedure access. A cath lab and procedure suites inside the ASC, scheduled with research cases in mind.
• Monitored observation. 8 monitored observation beds with continuous ECG telemetry inside the affiliated ASC.
• Same-day design. Stays are same-day and built to fit ASC admit-and-discharge rules. Monitoring, sampling and dosing windows are scoped with each sponsor during feasibility.
• One investigator team. Interventional, structural-heart and electrophysiology investigators working together, with bilingual staff.
• Quality systems. IAOCR GCSA certification and ICH-GCP E6(R3) compliant processes.

We describe the unit in more detail in our note on Phase 1 telemetry monitoring at our Miami cardiovascular site.

Where the startup time goes instead

Moving from a hospital to an ASC does not remove regulatory steps. IDE requirements under 21 CFR 812, IRB review under 21 CFR 56 and informed consent under 21 CFR 50 apply the same way. What changes is the number of organizations and calendars involved:

• Fewer decision makers. Site leadership, investigators and research operations sit close together, so budget and contract questions get answered by the people who will run the study.
• Central IRB. Most early-phase device studies at a non-academic site use an independent IRB, which removes the local committee cycle.
• Parallel work. Contract, budget, IRB submission and site training can run at the same time instead of one after another.
• Predictable scheduling. Procedure dates can be planned around the protocol rather than around the emergency schedule.

The startup timeline still depends on the protocol, the IRB and how fast the sponsor responds. We commit to timelines in the feasibility response, once we have seen the protocol, not in a blog post.

Enrollment: the patients are already in the practice

A fast start is only useful if patients follow. Our investigators see patients every week inside Amavita Heart and Vascular Health®, an independent Miami cardiovascular practice that has seen more than 16,000 patients in the last three years. Pre-screening starts from patients already in that care stream, which we explain in in-house cardiology practice vs referral network recruitment.

South Florida also helps with representation. About two in three Miami-Dade County residents identify as Hispanic or Latino, and the county has large Black and Caribbean communities. With bilingual coordinators in English, Spanish, Haitian Creole and Portuguese, sponsors can build enrollment that supports the diversity action plans the Food and Drug Omnibus Reform Act of 2022 requires for many pivotal studies. Early-phase data from a representative population makes that later plan easier to defend. Read more in FDA diversity action plans and cardiovascular site selection.

When an ASC is the wrong setting

Being honest about fit saves everyone time. An ASC research setting is a poor match when:

• The protocol requires overnight observation or inpatient admission.
• The procedure needs on-site cardiac surgery backup as a protocol requirement.
• The study population is mostly acute, emergency presentations, such as patients arriving with an active heart attack.
• Endpoints depend on imaging or labs that must be completed before a discharge the ASC cannot delay.

In those cases, we tell sponsors so during feasibility, and we can discuss a hybrid design in which a hospital site handles inpatient cases while the ASC handles the same-day cohort.

US and Latin America together

Many of our sponsors run their first human cases in Latin America with our sister organization, bioaccess®, and then need a US site for expansion. Amavita Research can serve as the US arm under one coordinated protocol and a single sponsor counterpart. That keeps the speed of a Latin American first-in-human study and adds US data before the pivotal discussion.

What to send for a feasibility review

The faster we see the right documents, the faster we can tell you whether the study fits. A useful first package is short:

• The protocol synopsis, including inclusion and exclusion criteria and the visit schedule.
• The procedure description, expected procedure time and post-procedure observation plan.
• Monitoring and sampling requirements during the observation window.
• The regulatory status of the device or drug and the IRB you plan to use.

From that, we can confirm whether the same-day setting works, which investigators fit, and how many eligible patients the practice sees.

Questions to ask any ASC-based research site

• Is the ASC licensed, Medicare-certified and accredited, and which body accredits it?
• How many monitored beds are available, and what monitoring runs on them?
• Who are the investigators, and do they perform these procedures in routine practice?
• Which IRB does the site use, and how are contracts and budgets approved?
• What happens if a participant needs hospital transfer?
• How many eligible patients does the practice see each month for this indication?

Request a site capability evaluation with Amavita Research at amavitaresearch.com. Send the protocol synopsis and we will reply with a feasibility assessment, the investigator team and a description of the ASC procedure and monitoring setup.