A cardiovascular Phase 1 unit inside a Miami ASC: 8 telemetry-monitored observation beds, same-day by design

Early-phase cardiovascular protocols have a scheduling problem that has little to do with science. The study needs a cath lab, a monitored bed, a cardiologist who can make a call in minutes, and a coordinator who can hit a sampling window to the minute. In a large hospital, each of those belongs to a different department with its own calendar. The protocol ends up competing with emergency cases and routine procedures for every slot.

I'm Julio Martinez-Clark, CEO of Amavita Research. We built our cardiovascular Phase 1 unit to solve that specific problem for a specific kind of study. This article explains what the unit is, what it is designed to do, and, just as important, what it is not designed to do, so a clinical operations director or medical monitor can decide quickly whether a protocol fits.

The early-phase bottleneck in hospital settings

Academic and hospital research programs do excellent work, and many complex early-phase studies belong there. But sponsors running smaller, procedure-heavy cardiovascular protocols tell us about the same friction points again and again:

• Shared procedure rooms. Research cases are scheduled around clinical demand, so a study procedure can slip when the lab is needed for an urgent case.
• Layered approvals. Contracting, budgeting, departmental sign-offs and institutional review often run in sequence rather than in parallel.
• Distance between the investigator and the bed. The physician who enrolled the participant may not be the one covering the observation period.
• Overhead that is sized for large programs. A protocol with a handful of participants carries much of the same institutional machinery as a large one.

None of this is a criticism of hospitals. It is a description of a system designed for many priorities at once. For a well-defined, same-day cardiovascular protocol, a smaller and more focused setting can be the better operational fit.

The ASC-embedded model

Amavita Research operates its cardiovascular Phase 1 unit with Advanced Cardiovascular of Miami, an affiliated cardiovascular ambulatory surgery center (ASC) in Kendall, Miami. The ASC is licensed, Medicare-certified and AAAHC-accredited, and it houses a cath lab and procedure suites. That gives our studies direct access to cardiovascular procedural infrastructure in the same building where participants are monitored.

What this changes in practice:

• Procedure, monitoring and investigator in one place. A participant can move from the procedure suite to a monitored bed without changing facilities, and the investigator team is on site.
• Cardiovascular-only focus. The ASC is built around cardiovascular procedures. Staff, equipment and workflows are oriented to the same patient population our protocols enroll.
• Investigators who practice. Our investigators are practicing cardiologists in the affiliated practice, amavita Heart and Vascular Health®. The physicians who know the procedures are the ones overseeing the study.

Eight telemetry-monitored observation beds

The unit has 8 monitored observation beds with continuous ECG telemetry inside the affiliated ASC. That number is deliberate. It is sized for early-phase cardiovascular cohorts where close observation of each participant matters more than throughput.

Continuous ECG telemetry supports the monitoring most cardiovascular Phase 1 protocols ask for: rhythm surveillance after a first dose or a first device use, and observation through the post-procedure window. Specific monitoring parameters, sampling schedules and dosing windows are scoped with each sponsor during feasibility, so the protocol's requirements drive the setup rather than the other way around.

Same-day by design

I want to be direct about scope, because it saves both of us time. The Phase 1 unit is a daytime outpatient setup. Stays are same-day and are designed to fit within ASC admit-and-discharge rules. We do not run overnight or multi-day confinement in this unit.

That makes the unit a strong fit for protocols such as:

• Cardiovascular device early feasibility or first-in-human procedures where the observation period after the procedure ends the same day.
• Cardiovascular drug Phase 1a or 1b dosing visits where the monitoring and sampling schedule fits within a single day.
• Follow-up visits that need telemetry monitoring and close investigator review but not an overnight stay.

It is not the right fit for protocols that require overnight residential stays, extended inpatient PK confinement, or critical-care backup inside the unit. If your protocol needs those, I would rather tell you at the feasibility call than after a budget round.

The investigator team

Phase 1 work at the unit draws on the same investigator team that runs our cardiovascular trials:

• Dr. Pedro Martinez-Clark, MD, FACC, founder and lead investigator, a Harvard-trained interventional cardiologist covering interventional, coronary and peripheral work.
• Dr. William W. O'Neill, MD, FACC, chief medical officer and senior principal investigator, with a structural-heart research background, in a consultative role on structural protocols.
• Dr. Hans C. Rutzen-Lopez, MD, sub-investigator for cardiac electrophysiology.
• Yasnaya Cruz-Santiago, APRN, and Orlando Ortega-Izquierdo, APRN, bilingual family nurse practitioners supporting general cardiology co-management and study conduct.

Our coordinators work in English, Spanish, Haitian Creole and Portuguese, which matters in Miami for consent conversations and visit-day communication. You can read full profiles on our investigators page.

Recruitment from a South Florida cardiovascular practice

Early-phase cardiovascular studies often fail on enrollment, not execution. Amavita Research operates inside the workflow of amavita Heart and Vascular Health®, an independent Miami cardiovascular practice that has seen more than 16,000 patients in the last three years. Trial-eligible patients can be identified during standard cardiology care by the same physicians who serve as investigators.

South Florida's population is diverse, and much of it is Hispanic and Caribbean. For sponsors thinking about diversity action planning, this is a practical advantage, not a slogan, because the patients are already in the practice. We have written separately about FDA diversity action plans and cardiovascular site selection.

Operational speed: what we can and cannot promise

Every sponsor asks how fast we can start. The honest answer is that it depends on the protocol, the IRB route and how quickly the contract and budget close. What we control is how we run the steps:

• Feasibility with a real answer. We tell you early whether the protocol fits the same-day ASC setting, which investigator would lead it, and what the unit would need.
• Parallel tracks. Contract and budget negotiation, regulatory document collection and IRB preparation run at the same time where the sponsor's process allows it.
• One decision-maker on the site side. Sponsor first-touch and contracting come to me directly. Operations, start-up logistics and IRB submissions are run by Nereisy Alonso, our chief operations officer.
• Quality framework. Amavita Research is IAOCR GCSA-certified and works to ICH-GCP E6(R3).

For a first protocol at the Phase 1 unit, we will give you a dated start-up plan after feasibility rather than a generic number.

A US arm for Americas programs

Amavita Research is part of the same research group as bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. For sponsors running a first-in-human study in Latin America and planning the next step in the United States, the Kendall Phase 1 unit can serve as the US arm, with bioaccess® running the Latin American arm and one coordinated counterpart across both. We describe that model in our post on US and Latin America cardiovascular trial site strategy.

Is your protocol a fit?

Before you send a synopsis, check these five questions:

1. Is the indication cardiovascular?
2. Does every visit, including the post-dose or post-procedure observation window, end the same day?
3. Is continuous ECG telemetry the main monitoring need, with no requirement for in-unit critical care?
4. Does the cohort size fit a unit with 8 monitored observation beds?
5. Do you need cath-lab or procedure-suite access during the study visit?

If the answers are mostly yes, we should talk. See our Phase 1 unit page, our site capabilities and our sponsor page, or reach the sponsor team through our sponsor contact form.

Julio Martinez-Clark, CEO, Amavita Research. Unit scope, monitoring and sampling requirements are confirmed per protocol during feasibility.