Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility
study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia due
to prior myocardial infarction will be enrolled and treated with the Sphere-9 Catheter
and A...
Age: 18 - 85 years
Gender: All
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment 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 a Medical Device
(SaMD) designed to compute ejection fraction (EF) severity categories based on the
America...
Age: 18 years - 66+
Gender: All
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment 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 a Medical Device
(SaMD) designed to compute ejection fraction (EF) severity categories based on the
America...
Age: 18 years - 66+
Gender: All
The Prevent Coronary Artery Disease Trial
Despite increasing evidence that exposure to cardiovascular risk factors (CVRF) at an early age increases the prevalence of subclinical atherosclerosis and is associated with a greater risk of cardiovascular events later in life, there is a lack of randomized trial evid...
Age: 30 - 50 years
Gender: All
Imaging Coronary Microvascular Dysfunction (CMD) Study
Angina is a common clinical symptom of ischemic heart disease, affecting up to 11 million
people in the United States alone, and 112 million people globally. Despite this, 4 in 10
patients undergoing elective coronary angiography for angina and ischemia do not have
e...
Age: 18 years - 66+
Gender: All
Imaging Coronary Microvascular Dysfunction (CMD) Study
Angina is a common clinical symptom of ischemic heart disease, affecting up to 11 million
people in the United States alone, and 112 million people globally. Despite this, 4 in 10
patients undergoing elective coronary angiography for angina and ischemia do not have
e...
Age: 18 years - 66+
Gender: All
XIENCE 28 USA Study
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary interventi...
Age: 18 - 100 years
Gender: All
A Medical Research Study to Evaluate the Effects of ACT-246475 in Adults With Coronary Artery Disease
The goal of this study is to find out if a drug called ACT-246475 can prevent platelets from
binding together when administered by an injection under the skin in the thigh or in the
belly. Another goal is to know how fast and for how long ACT-246475 works and if there...
Age: 18 - 85 years
Gender: All
Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)
The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for
use during high-risk percutaneous coronary interventions (PCI) performed electively or
urgently in hemodynamically stable patients with severe coronary artery disease, when a he...
Age: 18 - 100 years
Gender: All