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Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study.
A study to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds of POC, immediate-feedback AI-ECG + AI FoCUS screening for cardiac disea…
Reduction or Elimination of Mitral Regurgitation With the SATURN Trans-septal TMVR System in Patients With Severe, Symptomatic Mitral Regurgitation (Cassini-US)
CASSINI-US is a prospective, single-arm, multicenter early feasibility study enrolling up to 15 patients at up to 5 sites in the United States (US). The purpo…
Self-Expanding Coronary Sinus Reducer for Treatment of Symptomatic Coronary Microvascular Dysfunction (CMD)
VahatiCor's Coronary Sinus Reducer (A-FLUX) has been designed to improve angina or angina-like symptoms in patients with CMD. SERRA-I is an early feasibility s…
BOND HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Maternal and Infant Effects of a Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)
This is a two-arm, prospective, longitudinal, randomized controlled trial (RCT) that will compare usual care to usual care plus a prenatally initiated, virtual…
Health Care by Food Planning Grant
The goal of this study is to learn whether combining healthy food access with personalized tools can help families improve heart health and make lasting lifest…
University of Louisville - 18642 / CATO Study, Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy
This is a Phase IIA, randomized, double blind, placebo controlled, multicenter study designed to assess the safety, feasibility, and efficacy of umbilical cord…
Assessment and Validation of the Established Free-Running Framework for Cardiac Function by Magnetic Resonance Imaging (FAST-CMR): An International Multi-Center, Multi-Vendor Study at 1.5T
This project aims to evaluate a new cardiac MRI technique called the Free-Running Framework (FRF), which could simplify and accelerate the process of acquiring…
Development of a Novel Kidney-focused Approach to Treatment of a Patent Ductus Arteriosus (PDA) in Vulnerable Preterm Neonates - A Pilot Study
The goal of this observational study is to gather more information on kidney oxygen levels in babies with a patent ductus arteriosus (PDA), and evaluate the re…
Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring
This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared …
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as…
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT)…
BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease
The primary objective of this study is to enhance the rates of direct breast feeding (DBF) among infants with congenital heart disease (CHD), and to gain insig…