Systematic review of first-in-human and early phase clinical trials for surgically implantable biological mitral valve substitutes.

ABSTRACT:

Background

The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research.

Methods

An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position.

Results

Following the PRISMA guideline, a systematic search identified 2082 published articles until March 2023. After removing duplicates (189), 1862 citations were screened, resulting in 22 eligible studies with 3332

SUBMITTER: Sazzad F 

PROVIDER: S-EPMC10688009 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature