Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
Sphere-9 VT 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
Affer...
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
SELUTION 4 De Novo Small Vessel IDE Trial
Prospective, randomized controlled, single-blind, multicenter, clinical trial to
demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de
novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of
2.00 mm to ...
Age: 18 years - 66+
Gender: All
Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever
The objective of the DISTALS Study is to evaluate the safety and effectiveness of the
Tigertriever 13 Revascularization Device in restoring blood flow in the neurovasculature
by removing thrombus in patients presenting within 24 hours of onset with an ischemic
stroke...
Age: 18 - 85 years
Gender: All
Volumetric Integral Phase-shift Spectroscopy for Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology
The purpose of this study is to assess the ability of the Fluids Monitor to detect
hemispheric bioimpedance asymmetry associated with acute brain pathology in patients
presenting with suspected Acute Ischemic Stroke (AIS).
Age: 18 years - 66+
Gender: All