Funded Research Projects
Cottage Health researchers are leading 20-25 funded clinical projects annually. Projects from the Heart and Vascular Center, Neuroscience Institute, Cottage Children’s Medical Center, Pulmonary Hypertension Center as well as other areas of care are listed below:
Study Sponsor: Boston Scientific
Investigators: Joseph Aragon, MD (Principal Investigator), Brett Gidney, MD, Gregory Cogert, MD, Colin Shafer, MD
This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to Non-Vitamin K Antagonist Oral Anticoagulants (NOACs), in patients with non-valvular atrial fibrillation.
Study Sponsor: HRCRS/Biosense Webster
Investigator: Brett Gidney, MD
The REAL AF study is a prospective observational multicenter registry. The primary purpose of this registry is to obtain “real world” clinical use of commercially available novel radiofrequency (RF) technologies. This registry seeks to assess clinical outcomes, including procedural efficiency, safety, long-term, effectiveness of catheter ablation with novel RF technologies in PAF patients.
Study Sponsor: W.L. Gore & Associates, Inc.
Investigators: Joseph Aragon, MD (Principal Investigator), Michael Shenoda, MD, Philip Delio, MD
The GORE GSO 18-01 study is a Post Approval Study assessing the safety and effectiveness of the GORE Septal Occluder device as observed in the REDUCE pivotal IDE study, and evaluating the quality of operator education and training and transferability of trial experience to a post-market setting. The full study title is “GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval Study”.
Study Sponsor: NIH + University of Cincinnati
Investigator: Peter Nguyen, MD
The Multi-arm Optimization of Stroke Thrombolysis (MOST) trial aims to compare the safety and efficacy of argatroban and eptifibatide in the treatment of acute stroke. The primary efficacy objective is to determine if argatroban or eptifibatide result in improved acute stoke symptoms (compared to placebo), measured by 90-day modified Rankin scale. Patients will receive either argatroban or eptifibatide, along with IV rt-PA within three hours of symptom onset. Per usual care, patients may also receive endovascular thrombectomy. The primary safety objective will be measured by symptomatic intracranial hemorrhage within 36 hours from randomization.
Study Sponsor: Bayer
Investigator: Philip Delio, MD
The purpose of this study is to find the best dose of a new drug, BAY 2433334, to give to participants and look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non-cardioembolic ischemic stroke. This type of stroke occurs when a blood clot that has formed somewhere other than the heart travels to the brain. As an FXIa inhibitor, BAY 2433334 works by blocking a step of the intrinsic blood clotting process and thins the blood; however, does not affect the extrinsic pathway, which is initiated by vessel damage. This specificity offers the opportunity to prevent thrombosis without interfering in primary hemostasis. BAY 2433334 will be tested against placebo, added on top of antiplatelet therapy. The addition of BAY 2433334, a Factor XIa (FXIa) inhibitor, in combination with standard antiplatelet therapy is expected to be beneficial in the secondary prevention of stroke.
Study Sponsor: Balt USA
Investigators: Alois Zauner, MD (PI), Robert Taylor, MD, Akinwunmi Oni-Orisan, MD
STEM Study is a pivotal, international, multi-center, prospective, randomized controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH) in both surgically and medically managed patients. In surgical patients, embolization will be performed prior to burr hole drainage and is hypothesized to result in fewer re-accumulations/re-bleeds. In patients managed medically, embolization is hypothesized to result in greater reabsorption of the bleed.
Study Sponsor: Rapid Medical
Investigators: Robert Taylor, MD (PI), Alois Zauner, MD, Akinwunmi Oni-Orisan, MD
The purpose of this post-market surveillance study is to assess the safety and performance of the Comaneci Embolization Assist device as used in clinical practice in the United States. The Comaneci is a temporary neuroendovascular device used to stabilize coil placement in wide-necked intracranial aneurysms. The Comaneci device is similar to the remodeling balloons traditionally used in this setting, providing temporary support during coil embolization. Due to the expandable fine-wire mesh construction, the device eliminates the risk of parent vessel occlusion during coiling procedure and the need for long-term antiplatelet medication in case of permanent stenting.
Improving Outcomes for Very Low Birth Weight (VLBW) Infants
Project Sponsor: The James S. Bower Foundation
Investigator: Katherine Chung, MD, Steven Barkley, MD
The NICU at Cottage Children’s Medical Center, in collaboration with UCSB, propose to implement a multiple component Continuous Quality Improvement (CQI) program designed to improve outcomes for premature and ill infants and their families served in the Unit. The project will focus on introducing and adopting a set of best practices that have been developed for the treatment of very low birth weight infants (VLBW) and for providing psychosocial support for the families of the infants served in the NICU.
Investigator: David Slomiany, MD (PI)
Cottage Health is a member of the Children’s Oncology Group (COG), the world’s largest cooperative children’s cancer research entity. With active COG membership, Cottage Health has access to studies through the group to find the best treatments for children and adolescents with cancer. Cottage Health is the only COG site on the Central Coast and allows for local treatment of pediatric oncology patients.
More information of the Children’s Oncology Group
Cystic Fibrosis (CF) Patient Registry
Study sponsor: Cystic Fibrosis Foundation (CFF)
Investigator: Richard Belkin, MD (PI)
The Cottage Health Cystic Fibrosis and Bronchiectasis Clinic is a CF Foundation-accredited care center and active participant in the Cystic Fibrosis Patient Registry. The Patient Registry is used to create CF care guidelines, assist care teams providing care to individuals with CF, and guide quality improvement initiatives at care centers. In addition, the Patient Registry is utilized by researchers to study CF treatments and outcomes and to design CF clinical trials.
More information about the Cottage Health Fibrosis and Bronchiectasis Clinic
More information about the CF Patient Registry
Clofazimine Expanded Access
Study sponsor: Novartis
Investigator: Richard Belkin, MD (PI)
A multiple patient program for Lamprene® (clofazimine) for the treatment of Non-Tuberculous Mycobacterial (NTM) infections. Currently, clofazimine is only FDA-approved for the treatment of leprosy. This program allows for the use of clofazimine to treat NTM in a specific patient population.
Detection of Metabolic Changes of Blood and Urine in Human Sepsis Study
Investigator: Jeffrey Fried, MD (PI)
In collaboration with University of California, Santa Barbara, this NIH-funded study seeks to investigate components of blood and urine in sepsis patients. Sepsis is a disease caused by bacteria or other infectious organisms in the blood. The purpose of this study is to better understand the ways in which sepsis affects inflammation, coagulation, and metabolism. Blood samples are collected from participating patients in the SBCH ICU and are analyzed in a laboratory at UCSB.
Real-World Experience with Eravacycline at Academic Hospital Systems
Study Sponsor: Wayne State University
Investigator: Lena Kang-Birken (PI)
The purpose of this study is to describe the efficacy, safety, and reason to choose eravacycline in the real- world setting. The study will be a multicenter, retrospective, observational case series study of hospitalized patients treated with eravacycline between October 2018 and October 2019.
Rapid Diagnostic Test for Detection of Suspected Urinary Tract Infection (UTI)
Study Funder: ODx Innovations
Investigator: Jane Choe (PI)
A prospective observational study that seeks to explore the reliability of a rapid point-of-care diagnostic test that aims to confirm the presence of a urinary tract infection and identify the antimicrobial sensitivity of the etiological agent.