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Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

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Related Experiment Video

Updated: Apr 23, 2026

A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair

A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair

Published on: October 16, 2021

Tricuspid Valve Academic Research Consortium-2 (TVARC-2): Trial Design and Endpoints

Charles J Davidson¹, Rebecca T Hahn², J Hunter Mehaffey³

¹Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.

Journal of the American College of Cardiology

|April 22, 2026

Summary

The Tricuspid Valve Academic Research Consortium (TVARC) has established standardized definitions and endpoints for tricuspid regurgitation research. This work supports the development and evaluation of new transcatheter tricuspid valve interventions.

Keywords:

transcatheter tricuspid valve intervention tricuspid regurgitation tricuspid valve surgery

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Last Updated: Apr 23, 2026

A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair

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Published on: October 16, 2021

Protocol for Relative Hydrodynamic Assessment of Tri-leaflet Polymer Valves

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Published on: October 17, 2013

Chronic Ovine Model of Right Ventricular Failure and Functional Tricuspid Regurgitation

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Published on: March 17, 2023

Area of Science:

Cardiology
Medical Device Research
Clinical Trials

Background:

Tricuspid regurgitation (TR) management requires standardized approaches.
Previous TVARC efforts established disease definitions and trial endpoints.
Transcatheter tricuspid valve interventions have emerged as viable treatment options.

Purpose of the Study:

To define trial designs and endpoints for comparing emerging tricuspid valve technologies.
To facilitate rigorous evaluation of transcatheter interventions, surgery, and medical therapy for TR.
To advance the understanding and treatment of severe symptomatic tricuspid regurgitation.

Main Methods:

Review and synthesis of existing randomized trial data.
Analysis of regulatory approvals (FDA, CE Mark) for transcatheter tricuspid valve interventions.
Development of frameworks for future clinical trial designs.

Main Results:

Transcatheter edge-to-edge repair and valve replacement are FDA-approved and CE-marked.
Standardized definitions and endpoints are crucial for TR research.
Emerging technologies show promise for severe symptomatic TR patients.

Conclusions:

The TVARC framework guides future research in tricuspid regurgitation.
Standardized trial designs are essential for evaluating new TR therapies.
Continued research is needed to optimize patient selection and treatment strategies.