Current Clinical Trials

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
  1. Andrew Frutkin, MD
    Andrew Frutkin, MD
  2. for people 65 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started March 2022
  5. Andrew Frutkin, MD
  6. Currently not accepting new patients

Description

Summary

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis. This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3/SAPIEN 3 Ultra THV or Clinical Surveillance. Device Category: B Non-Experimental/Investigational Risk Level: Significant Risk Device Class: III

Official Title

CLOSED TO ENROLLMENT: PROGRESS: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement (TAVR)

Detailed Description

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance. ... more
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This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.

Keywords

Aortic Stenosis, Calcific

Eligibility

for people 65 Years and up
Key Inclusion Criteria: 65 years of age or older at time of randomization Moderate aortic stenosis Subject has symptoms or evidence of cardiac damage/dysfunction The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Key Exclusion Criteria: Native aortic annulus size unsuitable for the THV Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath... more
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Key Inclusion Criteria: 65 years of age or older at time of randomization Moderate aortic stenosis Subject has symptoms or evidence of cardiac damage/dysfunction The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. Key Exclusion Criteria: Native aortic annulus size unsuitable for the THV Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system Aortic valve is unicuspid or non-calcified Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification Pre-existing mechanical or bioprosthetic aortic valve Severe aortic regurgitation Prior balloon aortic valvuloplasty to treat severe AS LVEF < 20% Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR

Lead Scientist at Eisenhower Health

Andrew Frutkin, MD
Andrew Frutkin, MD, FACC, FSCAI is Board Certified in Internal Medicine, Cardiovascular Disease, Nuclear Cardiology and Interventional Cardiology. He is a Fellow of the American College of Cardiology and also of the Society of Cardiac Angiography and Interventions. “I find the practice of cardiology enormously stimulating and rewarding,” says Dr. Frutkin. “I am privileged to be able to help people at their time of greatest need. But, I also value greatly the opportunity to... more
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Andrew Frutkin, MD, FACC, FSCAI is Board Certified in Internal Medicine, Cardiovascular Disease, Nuclear Cardiology and Interventional Cardiology. He is a Fellow of the American College of Cardiology and also of the Society of Cardiac Angiography and Interventions.

 “I find the practice of cardiology enormously stimulating and rewarding,” says Dr. Frutkin. “I am privileged to be able to help people at their time of greatest need. But, I also value greatly the opportunity to sit down with patients in clinic and discuss their medical condition, diagnostic plan, and course of therapy. I strive for my patients to be fully-informed and educated so that they may make the right decisions that lead to a better lifestyle and health.”

Dr. Frutkin evaluates and treats people with all aspects of cardiovascular disease. He has specialized training in interventional cardiology to treat patients who have coronary artery disease, peripheral vascular disease, and structural heart disease. He has additional training in non-invasive imaging modalities of echocardiography, nuclear cardiology and CT angiography.

Dr. Frutkin attended Stanford University as a National Merit Scholar and David Starr Jordan Scholar and graduated with a Bachelor of Science with honors in biological sciences. He completed an internal medicine residency and cardiovascular disease fellowship at the University of Washington. While serving as faculty in the Cardiology Division at the University of Washington, he also engaged in a grant-supported research fellowship studying mechanisms of atherosclerosis and cardiovascular development using complex transgenic mouse models.  Dr. Frutkin then completed additional clinical training and research in interventional cardiology at St. Luke’s Mid America Heart Institute in Kansas City, Missouri, an internationally recognized center in cardiac care and research. Dr. Frutkin has presented abstracts at major national meetings and has published manuscripts in preeminent scientific and medical journals. Dr. Frutkin remains engaged in research as a sub-investigator on a number of device trials and he teaches in the Eisenhower Medical Center residency programs.

“I was drawn to medicine through my fascination with molecular biology and my desire to have a meaningful impact on people’s lives,” says Dr. Frutkin. “As cardiologists, we have experienced tremendous success in rigorously testing these medical advances in large clinical trials and applying those that work to the greatest benefit of our patients. Our professional societies have been instrumental in synthesizing and collating this ever-growing body of knowledge into practice guidelines. I use my knowledge and expertise to apply these evidence-based guidelines on an individualized basis to best treat my patients.”

Dr. Frutkin and his colleagues have developed the multidisciplinary Eisenhower Heart Valve Clinic to evaluate and treat patients who have complex heart disease. “One of our greatest advances has been the development of minimally invasive, catheter-based means to replace or repair diseased heart valves,” explains Dr. Frutkin. “Traditionally, open cardiac surgery was the only solution for patients who had diseased heart valves. However, some patients have been too ill or frail to undergo surgery safely. Now, new technology enables us to implant a new, prosthetic aortic valve or to repair a mitral valve in a patient’s failing heart through minimally invasive means, providing an effective and safer alternative to surgery for our most ill patients."

Clinical Study Details

  1. Currently not accepting new patients
  2. study started March 2022
  3. Interventional
  4. January 26, 2024