Cardiovascular Clinical Studies

This channel includes news and new technology innovations from cardiovascular clinical trials. These clinical studies include all cardiac subspecialties.

The approval is based on the results of SELECT, the largest cardiovascular outcomes trial ever completed for people with obesity and known heart disease

News | FDA

FDA Approves Wegovy for Cardiovascular Risk Reduction in Adults with Known Heart Disease and Overweight or Obesity

March 8, 2024 — Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an additional ...

March 08, 2024

Company’s AI-enabled technology for future heart attack risk assessment accepted into FDA’s TAP Pilot and to be validated in landmark TRANSFORM trial

News | FDA

Cleerly Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System

March 6, 2024 — Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart ...

March 06, 2024

Ensight-AI, a Yale start-up and leader in AI-based cardiovascular diagnostics, announces the receipt of the U.S. Food and Drug Administration’s (FDA) Breakthrough Device Designation for their ECGvision-TTR Technology

News | FDA

Ensight-AI Awarded FDA’s Breakthrough Device Designation for Its ECGVision-TTR Technology for Early Detection of ATTR-Cardiomyopathy

March 6, 2024 — Ensight-AI, a Yale start-up and leader in AI-based cardiovascular diagnostics, announces the receipt of ...

March 06, 2024

Bodyport Inc., a biomarker-guided predictive care company, has presented data showing its FDA-cleared, non-invasive, biomarker-based technology for remote heart failure monitoring detected twice as many heart failure events as compared to the weight-based standard of care.

News | Cardiovascular Clinical Studies

Bodyport Presents Preliminary Analysis of SCALE-HF 1 Study on Remote Heart Failure Monitoring at Technology and Heart Failure Therapeutics (THT) Conference

March 6, 2024 — Bodyport Inc., a biomarker-guided predictive care company focused on heart failure, announced data from ...

March 06, 2024

Lantheus announced that the U.S. Food and Drug Administration (FDA) has approved DEFINITY (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms, including those who have undergone heart transplant, or have Kawasaki disease or a congenital cardiovascular anomaly.

News | FDA

Lantheus Announces the FDA Approval of DEFINITY as Ultrasound Enhancing Agent for Use in Certain Pediatric Cardiovascular Patients

March 6, 2024 — Lantheus Holdings, Inc. (Lantheus), a radiopharmaceutical company, has announced that the U.S. Food and ...

March 06, 2024

Maternal stress may lead to adverse changes in mental, physical health that impact development of the fetal heart

News | Pediatric Cardiology

Severe Maternal Grief Associated with Increased Risk of Heart Failure in Child

March 1, 2024 — Prenatal stress is a potential risk factor for cardiovascular disease in offspring later in life. In a ...

March 01, 2024

News | Artificial Intelligence

New Studies: AI Captures Electrocardiogram Patterns That Could Signal a Future Sudden Cardiac Arrest

March 1, 2024 — Two new studies by Cedars-Sinai investigators support using artificial intelligence (AI) to predict ...

March 01, 2024

Five highly-anticipated late-breaking clinical trial sessions, an ACC/AHA guidelines update session and a host of featured clinical research sessions have been announced by program planners for the American College of Cardiology’s 73rd Annual Scientific Session & Expo to be held April 6-8 in Atlanta, GA.

News | ACC

American College of Cardiology ACC.24 Late-breaking Science and Guidelines Session Summary

February 29, 2024 — The American College of Cardiology (ACC) will soon be holding its ACC 73rd Annual Scientific Session ...

February 29, 2024

Gen 2 System has potential to reduce cardiac workload and enhance blood flow

News | Hypertension

Aria CV Announces First Patient Successfully Implanted with Second-Generation Pulmonary Hypertension System

February 27, 2024 — Aria CV, Inc, a developer of medical devices treating pulmonary hypertension, today announced the ...

February 27, 2024

Investigational device designed for Left Atrial Appendage Elimination (LAAX) to reduce the risk of stroke in patients with non-valvular atrial fibrillation

News | Atrial Fibrillation

Biosense Webster Begins Enrollment of Pivotal Trial Evaluating the Laminar Left Atrial Appendage Elimination Device 

February 27, 2024 — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & ...

February 27, 2024

The Ohio State University Wexner Medical Center is the first in central Ohio to take part in a global clinical trial to use a novel therapy to reduce the size of the left ventricle without open-heart surgery

News | Cardiovascular Clinical Studies

Ohio State First in Central Ohio to Use Novel Heart Failure Therapy

February 26, 2024 — More than 6 million Americans live with heart failure, and about half have an enlarged left ...

February 26, 2024

Visualization of the blood vessels in the brain of a patient without early venous filling, meaning without excessive reperfusion of the brain area after removal of the blood clot in the blocked artery.

News | Stroke

Arterial Connections Improve Treatment Outcomes Following Stroke

February 26, 2024 — Ischemic strokes are a major health burden. They occur when a blood vessel that supplies the brain ...

February 26, 2024

Wake Forest University School of Medicine, the academic core of Advocate Health, is expanding another research study to Advocate Christ Medical Center, in Oak Lawn, Illinois, just outside Chicago.

News | Heart Failure

Research Study on Novel Rehab Program for Heart Failure Patients, Led by Wake Forest University School of Medicine, Expands to Advocate Health Site in Chicago

February 22, 2024 — Wake Forest University School of Medicine, the academic core of Advocate Health, is expanding ...

February 22, 2024

First of its kind artificial heart valve now approved by FDA for treatment of tricuspid regurgitation.

News | Cardiovascular Clinical Studies

Henry Ford Health Heart Failure Patient First in Michigan to Receive Breakthrough Device

February 21, 2024 — An 80-year-old woman from Frankenmuth, Michigan is the first Henry Ford Health structural heart ...

February 21, 2024

The Medtronic APOLLO Clinical Trial is evaluating the safety and efficacy of an investigative device called the Intrepid Transcatheter Mitral Valve Replacement System (TMVR) for moderate-to-severe or severe symptomatic mitral regurgitation (MR) in patients who may be unsuitable for approved transcatheter repair or surgery.

News | Structural Heart

Hackensack Meridian Jersey Shore University Medical Center Providing State-of-the-Art Medtronic APOLLO Clinical Trial Treating Heart Valve Disease

February 20, 2024 — As New Jersey’s leading provider of high-quality cardiac procedures and diagnostic testing and an ...

February 20, 2024