The Christ Hospital Structural Heart ...

Dr. Santiago Garcia, MD

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The Christ Hospital

Studies Von Willebrand Disease
Studies Aortic Valve Disease
15 reported clinical trials
20 drugs studied

Affiliated Hospitals

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The Christ Hospital

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Abbott Northwestern Hospital

Clinical Trials Santiago Garcia, MD is currently running

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Proteomics Analysis

for Heart Valve Disease

The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis of HALT; to characterize changes in circulating proteins after treatment of HALT with systemic anticoagulation; and to identify circulating proteins that predict the occurrence of HALT. The study population will be adult patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) or bioprosthetic valve degeneration. Enrollment will continue until 30 patients with HALT are identified for completion of phase 1. Based on a HALT incidence rate of 10%, we anticipate enrolling 300 patients. Patients are enrolled prior to undergoing transfemoral TAVR. Blood samples, clinical data and echocardiograms will be collected at the following timepoints: baseline (pre-TAVR, T0), post-TAVR (pre-discharge, T1), 30-day follow-up (window 3-9 weeks, T2), and 6-month follow-up (T3). Cardiac 4D CT will be performed at the 30-day follow-up visit to screen for the occurrence of HALT. Patients with HALT will be treated with systemic anticoagulation for 5-6 months, at which point a follow-up CT scan and blood sample will be obtained. Control subjects will also undergo a 6-month study visit with blood sample collection. The study will be conducted within two phases. Phase 1 will serve as a derivation / discovery study in which candidate protein biomarkers of HALT will be identified. Once this is successfully completed, a second cohort will be enrolled within phase 2. Phase 2 will be performed under the auspices a future contract or amendment and will seek to cross-validate the initial study findings.

Recruiting

1 award

Phase 1

3 criteria

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J-Valve Transfemoral System

for Aortic Regurgitation

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

Recruiting

1 award

N/A

2 criteria

More about Santiago Garcia, MD

Clinical Trial Related

8 years of experience running clinical trials · Led 15 trials as a Principal Investigator · 4 Active Clinical Trials

Treatments Santiago Garcia, MD has experience with

  • Edwards PASCAL System
  • ACURATE Neo2™ Transfemoral TAVR System
  • Medtronic CoreValve TAVR System
  • Edwards SAPIEN 3 TAVR System
  • ACURATE Prime™ Transfemoral TAVR System XL
  • Sentinel® Cerebral Protection System

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