The Jewel P-WCD detects and treats life-threatening ventricular tachycardia and ventricular fibrillation, and is designed to promote compliance and fit into a patient’s daily life.
Providers:
Login to the clinical portal to access important information about the Jewel.
The Jewel P-WCD detects and treats life-threatening ventricular tachycardia and ventricular fibrillation, and is designed to promote compliance and fit into a patient’s daily life.
Providers:
Login to the clinical portal to access important information about the Jewel.
The Jewel Purpose and Overview
The Jewel continuously monitors a patient’s heart activity, detects ventricular tachycardia and ventricular fibrillation, and automatically delivers an electrical shock to restore normal heart rhythms.
You have prescribed the Jewel to your patient for a temporary period so that they are protected from specific life-threatening heart rhythms 24 hours a day, 7 days a week. The Jewel is not an implanted device. It is a device that is externally worn on the patient’s skin.
Clinical Trial Description
The Jewel IDE Study
A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest.
Objective
To demonstrate the safety and clinical effectiveness of the Jewel P-WCD.
Principal Investigators
Javed Butler, MD
University of Mississippi
- President of the Baylor Scott and White Research Institute, Dallas, TX
- Distinguished Professor of Medicine at the University of Mississippi Medical Center, Jackson, MS
- Over 650 Peer-reviewed Publications
- Member of Editorial Boards of Several Peer-reviewed Cardiovascular Journals
John Hummel, MD
The Ohio State University
- Director, Electrophysiology Section
- Professor of Cardiovascular Medicine
- Over 150 Publications in Cardiac Electrophysiology
Roxana Mehran, MD
Mount Sinai
Director of Interventional Cardiovascular Research and Clinical Trials
Chief Scientific Officer, Clinical Trials Center, Cardiovascular Research Foundation
Member, Board of Trustees, Society of Cardiac Angiography and Interventions
SCIENTIFIC ADVISORS
Christine Albert, MD, MPH
Cedars Sinai Medical Center
- Professor and Founding Chair of the Department of Cardiology at Cedars Sinai
- Epidemiologist at Brigham and Women’s Hospital
- Visiting Professor of Harvard Medical School
- Past President and current editorial member of the Heart Rhythm Society (HRS)
- Lee and Harold Kapelovitz Distinguished Chair in Cardiology in the Smidt Heart Institute at Cedars-Sinai
Bob Harrington, MD
Stanford University
- Interventional Cardiologist
- Arthur L. Bloomfield Professor of Medicine and Chairman of the Department of Medicine at Stanford University
- Former Director of the Duke Clinical Research Institute (DCRI)
- Author of more than 700 Articles and Edited Five Textbooks
- Former Member and Chair of US FDA Cardiovascular and Renal Drugs Advisory Committee
- Past President, American Heart Association
Harlan Krumholz, MD
Yale School of Medicine
- Cardiologist
- Director of Yale Center for Outcomes Research and Evaluation
- Harold H. Hines Jr Professor Yale School of Medicine
- Global Thought Leader on Outcomes Research
- Author of more than 1,400 Articles and Two Books
- National Academy of Medicine; Distinguished Scientist of the AHA
Karol Watson, MD, PhD
David Geffen School of Medicine at UCLA
- Director of the UCLA Women’s Cardiovascular Health Center, the UCLA-Barbra Streisand Women’s Heart Health Program, and the UCLA Fellowship Program In Cardiovascular Diseases
- Co-Director of the UCLA Program in Preventive Cardiology
- Ad hoc Chair of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Food and Drug Administration (FDA)
- Past chairperson of the scientific advisory board For Womenheart
- Past Vice President for the Association of Black Cardiologists (ABC)
- More than 100 publications and presentations
This product is not currently commercially available for sale in the U.S.