Cardiovascular Clinical Studies

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

Abbott announced the first patient has been enrolled in the ENVISION investigational device exemption (IDE) clinical trial. 
News | Cardiovascular Clinical Studies
Abbott Announces First Procedures in ENVISION Trial of Navitor TAVI System to Treat Patients With Severe Aortic Stenosis

March 25, 2024 — Abbott announced the first patient has been enrolled in the ENVISION investigational device exemption ...

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A bioelectronic mesh, studded with graphene sensors (red), can measure the electrical signal and movement of cardiac tissue (purple and green) at the same time.
News | Heart Failure
UMass Amherst Engineers Create Bioelectronic Mesh Capable of Growing with Cardiac Tissues for Comprehensive Heart Monitoring

March 25, 2024 — A team of engineers led by the University of Massachusetts Amherst and including colleagues from the Ma ...

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A clinical trial at Cedars-Sinai is testing the safety and efficacy of a device aimed at managing treatment-resistant hypertension. Photo by Getty.
News | Hypertension
Cedars-Sinai Experts Studying Device for Controlling Treatment-Resistant Hypertension

March 18, 2024 — The Smidt Heart Institute at Cedars-Sinai recently became one of four institutions in the U.S. and the ...

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Visual Thrombus Assessment as presented by Dr. William Gray at the Cardiovascular Research Technologies (CRT) 2024 conference.
News | Left Atrial Appendage (LAA) Occluders
Conformal Medical's CLAAS System Demonstrates Low Thrombogenicity Compared to Commercially Available LAAO Devices

March 18, 2024 — Conformal Medical, Inc. announced that the CLAAS System was featured in a podium presentation at the Ca ...

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First-of-its-kind trial in US shows drug-coated balloons are a superior treatment option for patients undergoing coronary angioplasty
News | Cardiovascular Clinical Studies
BIDMC-led Trial Leads to FDA approval of Coronary Drug-coated Balloons

March 13, 2024 — In the largest randomized clinical trial and first of its kind to date in the United States, a team led ...

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BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Centers for Medicare & Medicaid Services (CMS) approval for reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure.
News | Heart Failure
BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study

March 13, 2024 —  BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of ...

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Silence Therapeutics has announces positive topline 36-week data from its ongoing Phase 2 Study of Zerlasiran in patients with high Lipoprotein(a), reporting that the study met the primary endpoint and demonstrated highly significant reductions in Lp(a) to week 36.
News | Cardiovascular Clinical Studies
Positive Topline 36-Week Data from Ongoing Phase 2 Study of Zerlasiran in Patients with High Lp(a) Announced by Silence Therapeutics

March 13, 2024 — Silence Therapeutics has announced positive topline 36-week data from the ongoing ALPACAR-360 phase 2 ...

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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 ...

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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 ...

Home March 06, 2024
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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 ...

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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 ...

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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 ...

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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 ...

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Sumeet Chugh, MD. Photo by Cedars-Sinai
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 ...

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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 ...

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