First in Human Device Transplant in the US for CLASP Study Completed at Baylor Scott & White – The Heart Hospital Plano
- The CLASP Study is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes trial
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. The PASCAL System is designed to reduce the amount of mitral regurgitation without the need for open-heart surgery. Inclusion criteria include, but are not limited to: 18 years of age or older and clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). Full study inclusion and exclusion criteria will be provided by the study contact listed below.- Study Title: The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study.
- Trial Identifier: NCT03170349
- Study PI: Robert L. Smith II, MD
- Study Contact: Necole Kell
Necole.Kell@bswhealth.org
469.814.4871
Baylor Scott & White – The Heart Hospital Plano is the First Trial Site in the US to Implant SAPIEN 3 Transcatheter Valve
- PARTNER 3 MViV is a prospective, single-arm, multicenter study to investigate the safety and effectiveness of SAPIEN 3 Transcatheter Heart Valve implantation in patients with a failing mitral bioprosthetic valve
The study seeks to enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined). Inclusion criteria include, but are not limited to: 19 years of age or older; failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency; and NYHA Functional Class ≥ II. Full study inclusion and exclusion criteria will be provided by the study contact listed below.- Study Title: PARTNER 3 Trial – Mitral Valve in Valve
- Trial Identifier: NCT03193801
- Study PI: Robert L. Smith II, MD
- Study Contact:
Necole Kell
Necole.Kell@bswhealth.org
469.814.4871
Baylor Scott & White – The Heart Hospital Plano One of Only 5 in the U.S., and First in Texas, to Implant Tricuspid Valve Reconstruction System
- This is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System
The purpose of this early feasibility study is to test the safety and effectiveness of the Cardioband Tricuspid System and see what effects that it has on tricuspid regurgitation. Patients in this study will be among the first in the US to undergo reconstruction of their tricuspid valve using this investigational tricuspid reconstruction system. Inclusion criteria include, but are not limited to: 18 years to 85 years of age; chronic functional tricuspid regurgitation (moderate or greater); and symptomatic despite medical therapy. Full study inclusion and exclusion criteria will be provided by the study contact listed below.- Study Title: Edwards Cardioband™ Tricuspid Valve Reconstruction System Early Feasibility Study
- Trial Identifier: NCT03382457
- Study PI: Robert L. Smith II, MD
- Study Contact:
Necole Kell
Necole.Kell@bswhealth.org
469.814.4871
Baylor Scott & White – The Heart Hospital Plano First to Implant WiSE System in a Patient West of the Mississippi River
- This is a prospective, multi-center, randomized, controlled, double blinded, pivotal trial to study the safety and efficacy of the WiSE-LV System for Cardiac Re-synchronization Therapy (CRT)
The WiSE System is an implantable cardiac system to provide left ventricular pacing stimulation in conjunction with a co-implanted system that provides right ventricular stimulation. The purpose of this research study is to test the safety of the WiSE CRT System and determine what type of effects that it might have on heart failure. The WiSE CRT system is also known as WiSE, WiCS, or Wireless Cardiac Stimulation System. This device is being studied to test a new way to pace the left side of the heart without using pacing leads, using the WiSE CRT System. In this study, ultrasound will be used to transfer energy from a new type of pacemaker through the body to a special receiver that is placed inside the left ventricle of the heart. The receiver will use the ultrasound energy to pace the heart without using pacing leads. Inclusion criteria include, but are not limited to: 18 years of age or older and class I or IIa (1) or (2) indication for implantation of a (Cardiac Resychronization Defibrillator) CRT-D device according to current available guidelines. Full study inclusion and exclusion criteria will be provided by the study contact listed below.- Study Title: Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients (SOLVE CRT)
- Trial Identifier: NCT02922036
- Study PI:Steven Kindsvater, MD
- Study Contact:
Penni Dolton
Penni.Dolton@bswhealth.org
469.814.4735