From heart failure to structural interventions: what a dedicated Miami cardiovascular clinical site actually executes

Sponsors do not choose a cardiovascular site because the website lists every ICD-10 code in cardiology. They choose it because the indications they care about are actually executed there — with the right diagnostics, the right investigators and an observation setting that matches the protocol's monitoring demands. This article is a plain inventory of what Amavita Research runs in Miami, and what we do not pretend to run.

I'm Julio Martinez-Clark, CEO of Amavita Research. We are a cardiovascular clinical research site. If your protocol is not cardiovascular, this page will save you a call.

Core therapeutic indications in active execution

Our investigators and coordinators work across the cardiovascular problems that dominate South Florida specialty practice and device development:

• Heart failure, including HFpEF and HFrEF programs and evaluations of novel therapeutic approaches that fit outpatient or same-day monitoring designs.
• Hypertension, including refractory hypertension work and follow-up around renal denervation and related interventional pathways when the protocol is cardiovascular in design.
• Peripheral artery disease (PAD) and critical limb ischemia pathways tied to interventional cardiology practice.
• Electrophysiology: arrhythmia monitoring, ablation-related research and rhythm-management device protocols within our EP coverage.
• Structural heart: diagnostic monitoring and clinical follow-up endpoints that sit with our structural investigators, including programs that coordinate with procedure schedules at the affiliated ASC.
• Coronary and interventional cardiology studies that use the practice panel and procedure infrastructure rather than a distant hospital-only model.

Indication lists are not enrollment guarantees. Each protocol still faces criteria, windows and patient choice. The list above is the therapeutic neighborhood we live in every week.

Diagnostic and clinical infrastructure

Cardiovascular trials fail when the diagnostic suite is somewhere else and the coordinator spends the day chasing outside reports. Our site model keeps core cardiology diagnostics close to the investigators:

• Echocardiography capability spanning transthoracic studies and transesophageal echocardiography when the protocol and clinical setting require them.
• Vascular ultrasound for peripheral and related assessments.
• Continuous Holter and ambulatory rhythm monitoring workflows.
• Stress testing as part of cardiology evaluation pathways.
• Electronic data capture (EDC) compliance and source processes built for monitored trials, not for after-the-fact chart scavenger hunts.

Specific modality availability for a given protocol is confirmed at feasibility. We do not invent a scanner we do not control. If a study needs imaging beyond what we can schedule cleanly, we say so and discuss whether the protocol can still run with us as a cardiovascular prime site — a topic we covered in our note on imaging-enabled expansion.

Phase 1 and early-phase observation: eight telemetry beds, same-day

For early-phase and intensive outpatient monitoring, Amavita Research operates a cardiovascular Phase 1 unit with 8 monitored observation beds with continuous ECG telemetry inside the affiliated cardiovascular ambulatory surgery center Advanced Cardiovascular of Miami, in Kendall. The ASC setting puts procedure capacity and monitored recovery in one cardiovascular-focused building.

Design facts that matter for protocol fit:

• Continuous ECG telemetry for rhythm surveillance after dosing or device use.
• Same-day outpatient observation by design. Stays are built to fit ASC admit-and-discharge rules.
• We do not run overnight or multi-day confinement in this unit.
• Serial hemodynamic assessments and protocol-defined sampling windows are scoped during feasibility against what a same-day cardiovascular unit can actually deliver. We do not advertise an open-ended inpatient PK ward we do not operate.

That unit is a strong match for cardiovascular first-in-human or early-feasibility procedures with same-day observation, for cardiovascular drug Phase 1 visits whose monitoring fits a single day, and for follow-up visits that need telemetry and investigator presence without an overnight stay. It is the wrong match for residential confinement studies or protocols that need critical-care backup inside the research unit.

More detail on the unit itself sits in our Phase 1 telemetry article. This page is the indication and capability map around it.

Investigator coverage that matches the indications

Capabilities are people, not floor plans. Our cardiovascular investigator bench includes:

• Dr. Pedro Martinez-Clark, MD, FACC — interventional cardiology leadership across coronary and peripheral programs.
• Dr. William W. O'Neill, MD, FACC — structural-heart senior principal investigator in a consultative role on structural protocols.
• Dr. Hans C. Rutzen-Lopez, MD — electrophysiology sub-investigator coverage.
• Advanced practice providers supporting cardiology co-management and visit conduct, working in the languages our Miami patients actually use.

Profiles and credentials are published on our investigators page. Sponsors should match the protocol's primary endpoint to the investigator who will own it — EP endpoints to EP coverage, structural endpoints to structural coverage — instead of treating "cardiology site" as a generic label.

Sponsor partnership model

We run feasibility as a direct conversation:

1. You send the protocol synopsis or draft inclusion criteria.
2. We answer whether the indication sits in our active panel, which investigator would lead, whether the Phase 1 unit's same-day telemetry model fits, and what would block enrollment.
3. Contract, budget and IRB work proceed on parallel tracks when the fit is real.
4. Dedicated coordinators own the screening log and visit conduct once the site is open.

Quality sits under ICH-GCP E6(R3). Amavita Research is IAOCR GCSA-certified. The operating reality is a specialty cardiology practice, a dedicated research team and an affiliated cardiovascular ASC in Kendall.

Outpatient cardiovascular trials versus hospital-only assumptions

Many protocols arrive written as if every visit were an inpatient hospital day. In practice, a large share of cardiovascular device follow-up, hypertension programs, heart-failure drug studies and EP monitoring work can be executed in an outpatient specialty setting when the safety monitoring plan matches that setting. Our job at feasibility is to separate protocols that truly need a hospital bed from protocols that only inherited hospital language from an older template.

Same-day ASC observation with continuous ECG telemetry covers a useful early-phase band. Hospital inpatient units cover a different band. Mixing those assumptions without saying so is how sponsors lose months. We would rather redraw the visit table with you early than discover on day one that the monitoring schedule does not fit Kendall.

Coordination with procedure days

Interventional, structural and EP protocols often live or die on procedure-day choreography: consent timing, pre-procedure labs, device accountability, and post-procedure telemetry windows. Because the research team sits with the cardiovascular ASC and the practice, we plan those days as one calendar instead of as a negotiation between unrelated departments. That does not make every protocol easy. It does make the friction visible before the first patient is scheduled.

What we will not claim

• No current non-cardiovascular study portfolio dressed up as "multi-therapeutic."
• No overnight Phase 1 confinement.
• No guaranteed enrollment numbers on a public blog.
• No named commercial partners or investigational product identities in public content.

Those limits are deliberate. They keep feasibility honest.

How to use this page in a site-selection packet

If you are building a cardiovascular site list, take three things from this article into your internal memo:

1. Indication neighborhood: heart failure, hypertension, PAD, EP, structural and coronary interventional research.
2. Diagnostics: echo, vascular ultrasound, Holter, stress, EDC-ready source processes — confirmed per protocol.
3. Early-phase shell: 8 continuous-ECG telemetry observation beds in the Kendall cardiovascular ASC, same-day only.

Then ask us for a protocol-specific feasibility note. The public map gets you to the right conversation. The feasibility note decides whether we open a slot.

Contact the Amavita Research team at amavitaresearch.com to review protocol feasibility and site capabilities. Bring the indication, the monitoring schedule and the visit structure. We will map them to the practice, the investigators and the telemetry unit without padding the story.