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Baylor Scott & White Research Institute Drives Success for TAVR Clinical Trials as #1 Site Performer for PARTNER 3 & Evolut LR Trials

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Baylor Scott & White Research Institute Drives Success for TAVR Clinical Trials as #1 Site Performer for PARTNER 3 & Evolut LR Trials

The FDA recently approved a minimally invasive open-heart surgery alternative for low surgical-risk patients following the successful outcome of the PARTNER 3 and Evolut LR clinical trials. Baylor, Scott & White The Heart Hospital—Plano and Baylor Scott & White Medical Center—Temple participated in the PARTNER 3 trial while Baylor Scott & White Heart and Vascular Hospital—Dallas participated in the Evolut LR trial following FDA approval of the transcatheter aortic valve replacement (TAVR) for inoperable patients in 2012, high-risk patients in 2014 and medium-risk patients in 2017.

Background

An estimated 1.5 million people in the U.S. have aortic stenosis, which is a narrowing of the main heart valve that impedes blood flow from the heart. Unlike traditional open-heart surgery, TAVR allows physicians to deliver the new aortic valve via a catheter usually through a blood vessel in the leg. This approach has decreased complications and shortened recovery time to one day, rather than several days in the hospital.

Clinical Investigator Site Performance for PARTNER 3 & Evolut LR Trials

Baylor Scott & White Health hospitals enrolled the highest number of enrollees in the two trials combined of any health system in America. The research center’s 15-year history with TAVR began in 2004 in Leipzig, Germany with investigators from Baylor Scott & White The Heart Hospital—Plano (then called the Heart Hospital Baylor Plano) working with German colleagues. TAVR was performed on humans in early clinical trials less than three years later in the U.S. Baylor Scott & White is home to Texas’ largest TAVR program, having performed more than 3,600 TAVRs and is a top-five provider of TAVR nationally.

Investigator Comment

Michael Mack, MD, co-principal Investigator of the PARTNER 3 Trial and medical director of cardiovascular service line for Baylor Scott & White Health commented, “This is a momentous shift to have a disease that’s historically been mainly treated by open-heart surgery now is treated with a catheter-based approach.” He continued, “This approval underscores the importance and value of this research and demonstrates our commitment to improve care options for patients with aortic stenosis.”

TAVR Services

The following Baylor Scott & White hospitals offer TAVR

  • Baylor Scott & White The Heart Hospital—Plano
  • Baylor Scott & White The Heart and Vascular Hospital—Dallas
  • Baylor Scott & White All Saints Medical Center—Fort Worth
  • Baylor Scott & White Medical Center—Temple

About Baylor Scott & White Research Institute

The Baylor Scott & White Research Institute (BSWRI) promotes and supports research to bring innovative treatments from the laboratory workbench to the patient’s bedside. They have facilities in Dallas, TX and Temple, TX. They strive to be one of the world’s leading research centers for translational medicine.

BSWRI, an affiliate of Baylor Scott & White Health, offers 5.3 million patient encounters annually, 6,600 medical staff members and 49 hospitals that are owned, operated, joint-ventured or affiliated. With 600 employees, BSWRI runs more than 243,000 square feet of research space. Award-winning scientists and medical professionals conduct more than 2,000 active research protocols, spanning 58 medical specialties.

Lead Research/Investigator

Michael Mack, MD, co-principal Investigator of the PARTNER 3 Trial and medical director of cardiovascular service line for Baylor Scott & White Health

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