Research
Cardiovascular Clinical Trials
The Cardiovascular Clinical Research Unit in Sacramento conducts clinical trials in conjunction with various pharmaceutical companies and members of our clinical faculty. Several primary investigators on our faculty also oversee laboratory research on the UC Davis campus.
This research unit performs Phase I, II, III and IV clinical trials studying both drugs and medical devices. Protocols for these studies are approved for testing by the U.S. Food and Drug Administration and examined for ethical consideration by the UC Davis Human Subject Review Committee. The contractual arrangements for these studies are reviewed and approved by the Office of Research at UC Davis.
The Cardiovascular Clinical Research Unit has over 10 years of experience in all areas of cardiology, including congestive heart failure, unstable angina, hypertension, hyperlipidemia, electrophysiology and myocardial infarction. The current studies include investigations of:
- Valve replacements for patients with aortic stenosis
- Embolic protection for patients who are undergoing TAVR
- Clips for patients with mitral or tricuspid regurgitation
- CRT-D/ICD devices for people with non-ischemic cardiomyopathy
Active Clinical Trials
TRICAV-I: A prospective, multicenter clinical trial of the TricValve® Transcatheter Bicaval Valve System in subjects with severe tricuspid regurgitation.
Study objective: The TricValve® Transcatheter Bicaval Valve System for improving outcomes in symptomatic subjects with severe TR deemed by the local Heart Team to be at high risk for tricuspid valve surgery.
Detailed list of eligibility criteria: https://clinicaltrials.gov/study/NCT06137807?term=tricav&rank=1
Principal Investigator: Gagan Singh, MD
COMET_HF: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction
Study objective: To evaluate the efficacy of omecamtiv mecarbil compared with placebo on the risk of HF outcomes in patients with symptomatic HFrEF and severely reduced ejection fraction in the setting of guideline-directed medical therapy per local standard of care.
Detailed list of eligibility criteria: https://clinicaltrials.gov/study/NCT06736574?term=comet%20hf&rank=1
Principal Investigator: Shirin Jimenez, MD
ALLAY-HF Study: Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure
Study objective: To evaluate the safety and efficacy of the Alleviant ALV1 System in patients with chronic heart failure and preserved ejection fraction or mildly reduced ejection fraction, who remain symptomatic despite appropriate guideline directed medical therapy.
Detailed list of eligibility criteria: https://clinicaltrials.gov/study/NCT05685303?term=allay&rank=3
Principal Investigator: Tai Pham, MD
ALLAY-HFrEF Study: Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients with Heart Failure and Reduced Ejection Fraction
Study objective: To evaluate the safety and efficacy of the Alleviant ALV1 System in patients with heart failure with reduced ejection fraction (EF ≤ 40%) who remain symptomatic despite optimal maximally tolerated guideline directed medical therapy.
Detailed list of eligibility criteria: https://clinicaltrials.gov/study/NCT06812533?term=allay&rank=2
Principal Investigator: Tai Pham, MD
US GPS: The Global Paradise System US Post Approval Study
Study objective: The objective of the Global GPS Registry, including the US arm of the Global Paradise System Post Approval Study (US GPS), is to evaluate the real-world use of the Paradise System.
Detailed list of eligibility criteria: https://clinicaltrials.gov/study/NCT06297291?term=paradise%20gps&rank=1
Principal Investigator: Surabhi Atreja, MD