---
title: "Structural Heart Disease Clinical Trials — Patient Guide | Amavita Research"
url: https://md.amavitaresearch.com/blog/structural-heart-disease-clinical-trials-patient-guide
canonical: https://www.amavitaresearch.com/blog/structural-heart-disease-clinical-trials-patient-guide
schema_type: Article
last_updated: 2026-05-13
---

# Structural Heart Disease Clinical Trials — Patient Guide

Structural heart disease (SHD) covers conditions affecting the heart's valves, walls, and chambers — including aortic stenosis, mitral regurgitation, tricuspid regurgitation, patent foramen ovale (PFO), and left atrial appendage occlusion (LAAO). Clinical trials in this area test new devices and procedures, many of them minimally invasive transcatheter approaches.

## What SHD clinical trials test

- Transcatheter aortic valve replacement (TAVR) devices and protocols
- Transcatheter mitral valve repair/replacement (TMVR)
- Transcatheter tricuspid valve repair (TTVR)
- PFO closure devices and antithrombotic regimens
- LAAO devices for stroke prevention in atrial fibrillation
- Adjunctive procedures (annular reduction, leaflet repair)

## Investigator depth at Amavita Research

- **Dr. William W. O'Neill, MD, FACC** — Structural heart consultant. National PI on Edwards PARTNER, Protect II, Protect IV trials. Performed the first TAVR in the United States. https://www.amavitaresearch.com/team/william-oneill
- **Dr. Pedro Martinez-Clark, MD, FACC** — Worldwide PI on the Percutaneous Mitral Valve Annuloplasty trial. https://www.amavitaresearch.com/team/pedro-martinez-clark

## Who typically qualifies for an SHD trial

Eligibility varies a lot by indication. Examples:

- **TAVR trials**: severe symptomatic aortic stenosis confirmed by echocardiography
- **Mitral valve trials**: moderate-to-severe mitral regurgitation with symptoms or LV dysfunction
- **PFO closure trials**: cryptogenic stroke with PFO confirmed by TEE
- **LAAO trials**: non-valvular AFib with high stroke risk and bleeding contraindication to long-term anticoagulation

The trial protocol specifies exact eligibility criteria.

## What patients can expect

- Free trial-related care — study device, study procedures, study tests
- Bilingual coordinators (English / Spanish / Haitian Creole / Portuguese)
- Co-management with your cardiologist and (where applicable) cardiac surgeon
- Heart team review for invasive trials
- Procedures typically performed at affiliated cath-lab or surgical center
- Follow-up echocardiograms, ECGs, and clinic visits at protocol-defined intervals
- 24/7 contact number for trial-related questions

## How enrollment works

1. Your cardiologist or cardiac surgeon refers you, or you call directly: (786) 703-5941
2. Coordinator does a brief screening call
3. Screening including imaging (echo, possibly TEE or cardiac CT)
4. Heart team review for invasive protocols
5. PI confirms eligibility
6. Informed consent — take it home, read it, ask questions, decide

You can withdraw at any time, for any reason.

## Key links

- Therapeutic area: https://www.amavitaresearch.com/therapeutic-areas/structural-heart-disease
- Investigators: https://www.amavitaresearch.com/investigators
- Dr. William W. O'Neill profile: https://www.amavitaresearch.com/team/william-oneill
- What is TAVR: https://www.amavitaresearch.com/blog/what-is-tavr-transcatheter-aortic-valve-replacement
- Patient FAQ: https://www.amavitaresearch.com/faq-patients
- What to expect: https://www.amavitaresearch.com/blog/what-to-expect-cardiovascular-clinical-trial
- Contact: https://www.amavitaresearch.com/contact-patient · (786) 703-5941