8 telemetry-monitored observation beds: de-risking early feasibility cardiovascular protocols in Miami

Ask anyone who has run a cardiovascular early feasibility study what slowed it down, and the answers rarely start with the device. They start with logistics on procedure day. The cath lab slot moved. The monitored bed was not available. The post-procedure observation window had to be shortened or rescheduled. In an early study with a handful of subjects, each of those events is a meaningful share of the data.

I'm Julio Martinez-Clark, CEO of Amavita Research. We run cardiovascular trials in Miami, including early-phase and first-in-human work through our Phase 1 unit at an affiliated cardiovascular ambulatory surgery center. This article explains how we think about acute monitoring for early feasibility protocols, what our infrastructure is and is not, and what sponsors should ask any site before placing a novel catheter-delivered device there.

The acute monitoring bottleneck

Early feasibility studies for cardiovascular devices are designed to answer early questions in a small number of subjects: can the device be delivered, deployed and, where relevant, retrieved; does it function as intended; what happens in the hours after the procedure. FDA's 2013 guidance on early feasibility IDEs describes this stage, typically fewer than 10 initial subjects, with device and protocol modifications expected as the team learns.

Small numbers make every procedure day count. The protocol usually calls for continuous rhythm monitoring and frequent vital signs during a defined observation window after the procedure, with pre-specified criteria for escalation. That window is when the most informative early safety data are collected.

In a large hospital, monitored beds serve the whole institution. A research subject recovering from an investigational procedure is one of many patients who need telemetry, and clinical admissions understandably take priority. Research teams work hard to plan around that, but the dependency is structural. When monitored capacity is shared, the study's schedule is shared too.

What our Phase 1 unit has

Our early-phase work runs at Advanced Cardiovascular of Miami, an affiliated, licensed, Medicare-certified, AAAHC-accredited cardiovascular ambulatory surgery center in Kendall. The facts that matter for an early feasibility protocol:

• 8 monitored observation beds with continuous ECG telemetry inside the affiliated ASC.
• Cath lab and procedure suite access within the same ASC, so the procedure and the observation period happen under one roof.
• Same-day by design. Stays are designed to fit within ASC admit-and-discharge rules. We do not offer overnight confinement, and protocols that need multi-day inpatient observation are not a fit for this unit.
• Investigators across the relevant subspecialties. Interventional cardiology led by Dr. Pedro Martinez-Clark, structural heart consultative input from Dr. William W. O'Neill, and electrophysiology from Dr. Hans C. Rutzen-Lopez. Their backgrounds are on our investigators page.

That combination is useful for a specific profile of protocol: a catheter-based or transcatheter procedure with a same-day observation window, where continuous ECG monitoring and quick access to the procedure team matter. We described the unit in more detail in our overview of the Phase 1 unit. This piece is about how it applies to early feasibility device protocols.

Infrastructure requirements for early feasibility cardiovascular protocols

Whatever site you choose, these are the infrastructure questions I would put in the feasibility questionnaire.

Continuous telemetry and who watches it

Telemetry is as good as the people watching it. Ask who monitors the rhythm in real time, what the alarm thresholds are, and how the monitoring is documented for source verification. For an early feasibility study, the telemetry record is source data.

Emergency readiness

Crash cart readiness, defibrillation capability, airway management and staff certification are baseline expectations at any site doing interventional work. For an investigational device, add device-specific contingencies: what is the bailout if deployment fails, what equipment must be in the room, and who on the team has trained on it.

Procedure access

The cath lab schedule is a study resource. Ask how investigational cases are scheduled, how far ahead slots can be held, and what happens when a clinical emergency displaces a research case.

Escalation pathway

An ASC-based protocol must define, before the first subject, the criteria and route for transfer to hospital care if a subject needs a higher level of care or a longer stay. The protocol, the site and the IRB should all be reading the same pathway.

Device handling and accountability

Early feasibility devices often arrive in small lots, sometimes with design revisions between subjects. Storage, labeling, accountability logs and return procedures need to handle version control without confusion.

Our site-level details, including diagnostics and quality systems, are on the site capabilities page.

Patient safety protocols for catheter-delivered implants and transcatheter interventions

Safety in an early feasibility study is designed into the protocol, then executed at the site. The elements we expect to see and help sponsors refine:

1. Subject selection. Inclusion and exclusion criteria that favor anatomies and risk profiles where the early questions can be answered with acceptable risk. The investigator's practice panel helps here, because the team knows the patients' histories and imaging before screening.
2. Staged enrollment. Often a pause after the first subject or first few subjects for safety review before proceeding, sometimes with an independent reviewer or data safety monitoring board.
3. Defined observation window. A post-procedure monitoring period with continuous ECG, vital signs, access-site checks and protocol-specific assessments, sized to fit a same-day setting when the unit is the ASC.
4. Stopping and escalation rules. Pre-specified events that pause enrollment or trigger escalation of care, written in terms the site team can act on in real time.
5. Follow-up that matches the risk. Discharge criteria, a next-day contact, and scheduled follow-up visits with imaging and rhythm monitoring as the protocol requires.
6. Change control between subjects. If the device or procedure changes after early cases, as FDA's early feasibility framework anticipates, the change goes through the sponsor's IDE process and IRB review before the next subject is treated.

Startup velocity without promises we cannot keep

Sponsors ask us how fast we can start. I will not put a number of days on a public page, because start-up time depends on the protocol, the IRB, the contract and the device's IDE status. What I can describe is how we remove waiting from the process.

• IRB strategy. We prefer a central IRB, and our team has worked with both WCG and Advarra. A local IRB is available if the sponsor requires one. Using the sponsor's single IRB of record avoids a second layer of review.
• Parallel workstreams. Contract, budget, IRB submission and site readiness (staff training, device storage, procedure-day planning) run in parallel, owned by a named coordinator, instead of in sequence.
• Feasibility that reflects the real schedule. We confirm the observation window, monitoring intervals, sampling and cath lab time against the ASC's same-day rules during feasibility, so the protocol does not discover a conflict on the first procedure day.
• Quality systems that are already in place. Amavita Research is IAOCR GCSA-certified and works to ICH-GCP E6(R3). Monitors arrive to existing SOPs, not to a site building them for the first time.

When this unit is not the right fit

Being clear about limits saves everyone time. Our Phase 1 unit is not the right place for protocols that require overnight or multi-day monitored stays, open surgical procedures, or intensive care support beyond what an ASC setting provides. For those protocols we will say so during feasibility. For sponsors running parallel first-in-human work abroad, our sister organization bioaccess® runs the Latin American arm, and the US work can follow at Amavita Research.

Bring the protocol synopsis

If you are planning a cardiovascular early feasibility study and want to test it against a same-day ASC setting with continuous ECG telemetry, send us the procedure description, the observation window, the monitoring schedule and the escalation criteria. We will map them to the unit, the cath lab schedule and the investigators, and tell you plainly whether it fits. Send it through the sponsor contact form, and read about the investigators in the meantime.