Patient FAQ

For most trials, yes. Compensation typically covers your time, transportation, and parking — usually $50–$200 per visit, with totals ranging from $300 to $2,500 depending on the trial length and number of visits. The exact amount is disclosed in the informed consent form before you decide to join. Some trials cover additional expenses like meals or childcare during long visits.

Every trial at Amavita Research is reviewed by an independent Institutional Review Board (IRB) before it opens — the IRB's job is to make sure the trial is safe and ethical. Your trial has a designated principal investigator (a cardiologist), a study coordinator who follows you closely, and 24/7 access to medical care if any side effect occurs. All trials follow ICH-GCP E6(R3) — the international gold standard for patient safety in research.

Call the study coordinator listed on your consent form — we provide a 24/7 number, not a business-hours line. Adverse events are documented within 24 hours, evaluated by your principal investigator, and reported to the IRB and the trial sponsor on the timelines they require. Care for any side effect related to the trial is provided regardless of cost — that's part of the sponsor's commitment in every trial we run.

Yes — at any time, for any reason. This is a fundamental right of trial participation, written into your informed consent form. There are no penalties, no costs, and your standard cardiology care at amavita Heart and Vascular Health® continues unchanged. We do ask that you let your study coordinator know so we can schedule a brief safety follow-up — that's for your benefit, not the sponsor's.

No. Trial participation is in addition to your standard cardiology care, not a replacement. Your regular cardiologist at amavita Heart and Vascular Health® stays involved throughout. If your trial uses an investigational medication or device, the study team reviews it alongside your normal medications to make sure nothing conflicts. We communicate with your existing care team so everyone stays on the same page.

No. Trial-related visits, tests, study medications, and the investigational treatment are paid for by the trial sponsor — not by you or your insurance. Your insurance is only used (with your permission) for any standard-of-care visits that would happen even without the trial. If you don't have insurance, that doesn't disqualify you from most cardiovascular trials.

Yes. Amavita Research follows HIPAA and the trial's own privacy protocol. Your name is replaced with a study ID number in all trial records sent to the sponsor — the sponsor never sees your name, just the study ID. Only the site team needs to know your identity. Your information is not sold to third parties or used for marketing.

Visit amavitaresearch.com/trials to see open trials and inclusion criteria. Or call (786) 703-5941 to speak with a study coordinator who can screen you against currently active trials. Most trials require a brief in-person visit to confirm eligibility — that visit is free, and you're under no obligation to enroll after it.

Each trial has a Principal Investigator (PI) — at Amavita Research that's Dr. William W. O'Neill, Dr. Pedro Martinez-Clark, Dr. Hans C. Rutzen-Lopez, or another board-certified cardiologist depending on the indication. The PI is responsible for your medical care during the trial and makes the final decision on enrollment, safety, and any changes to your participation.

It varies by trial. A typical cardiovascular feasibility trial requires 6–12 visits over 6 to 24 months. Each visit takes 1–3 hours. Some trials add brief phone check-ins between visits. All of this is disclosed in the informed consent form before you enroll — we want you to understand the full commitment up front, not discover it visit by visit.

Usually no — most investigational products are only available during the trial. If the FDA approves the drug or device after the trial completes, your study coordinator can connect you with information about how to access it commercially. Some sponsors offer extended-access programs for participants who benefited during the trial; if that's available, the study team will tell you.

We can add you (with your permission) to a screening registry for upcoming cardiovascular trials. When a trial opens that matches your profile, the study coordinator reaches out. There's no cost to be on the registry, your information stays private, and you can be removed at any time by calling (786) 703-5941 or emailing research@amavita.health.