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
ACURATE IDE
Full study name: Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects Indicated for TAVR
Summary of trial: This randomized study focuses on patients who have severe aortic stenosis and who are considered at intermediate or greater risk for a surgical valve. Aortic stenosis occurs when the opening of the aortic valve is narrowed, thereby restricting the blood flow through the valve and causing the heart to have to work harder. The purpose of the study is to compare the performance of the investigational aortic valve, ACURATE neo Aortic Bioprosthesis, to commercially available, balloon-expandable valves through a transcatheter approach.
- Key inclusion:
- Participant has documented severe symptomatic native aortic stenosis
- Functional status is NYHA Functional Class ≥ II
- Heart team agrees participant is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate
- Key exclusion:
- Participant has unicuspid or bicuspid aortic valve
- Participant has a pre-existing prosthetic aortic or mitral valve
- Participant has severe (4+) aortic, tricuspid, or mitral regurgitation
Detailed list of eligibility criteria
Principal Investigator
Jeffrey Southard, M.D.
Contact
Karen Kan
916-734-7199
kckan@ucdavis.edu
Early TAVR
Full study name: Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis
Summary of trial: This randomized study focuses on patients who have severe aortic stenosis and are asymptomatic. Aortic stenosis occurs when the opening of the aortic valve is narrowed, thereby restricting the blood flow through the valve and causing the heart to have to work harder. The purpose of the study is to see if performing a transcatheter aortic valve replacement (TAVR) before patients show symptoms is helpful in preventing symptoms and unplanned cardiovascular hospitalizations.
- Key inclusion:
- 65 years or older at time of randomization
- Participant has severe, asymptomatic aortic stenosis
- STS risk score ≤ 10
- Key exclusion:
- Participant is symptomatic
- Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR or is non-calcified
- Pre-existing mechanical or bioprosthetic valve in any position
Detailed list of eligibility criteria
Principal Investigator
Jeffrey Southard, M.D.
Contact
Karen Kan
916-734-7199
kckan@ucdavis.edu
BIO-Libra
Full study name: Analysis of Both Sex and Device Specific Factors on Outcomes in patients with Non-Ischemic Cardiomyopathy
Summary of trial: This study focuses on men and women with non-ischemic cardiomyopathy — which is a weakening of the heart muscle that’s not caused by coronary artery disease or a heart attack — who are treated with implanted ICD and CRT-D devices. Since heart disease is the number-one cause of death for women, the study is looking to have a special focus on women. The purpose of the study is to see if there are any notable differences in treatment response based upon sex or type of device.
- Key inclusion:
- Participant meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
- Participant has non-ischemic etiology of cardiomyopathy
- Participant is willing to utilize BIOTRONIK Home Monitoring via CardioMessenger
- Key exclusion:
- Participant meets secondary prevention ICD indication
- Participant has ischemic etiology of cardiomyopathy
- Participant is expected to receive heart transplantation or ventricular assist device within 1 year
Detailed list of eligibility criteria
Principal Investigator
Uma Srivatsa, M.B.B.S., MAS
Contact
Karen Kan
916-734-7199
kckan@ucdavis.edu
Expand G4
Full study name: A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System
Summary of trial: This study focuses on patients with moderate to severe mitral regurgitation, which occurs when the two mitral valve leaflets do not properly close. This results in blood leaking backwards through the valve and, in turn, causes the heart to have to pump harder. This study uses the MitraClip System, which is already FDA-approved, to pinch the leaflets together and prevent the backflow of blood. Since the MitraClip System is not an investigational device, the purpose of the study is solely to collect information on its use and outcomes in everyday medical treatment.
- Key inclusion:
- Significant symptomatic mitral regurgitation (MR ≥ 3+) due to the primary abnormality of the mitral apparatus (degenerative MR)
- Symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation
- Symptomatic, moderate-to-severe MR (MR ≥ 3+) of mixed etiology
- Key exclusion:
- Participants who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regimen
- Participants with known hypersensitivity to clip components (nickel/titanium, cobalt, chromium, polyester), or with contrast sensitivity
- Active endocarditis of the mitral valve
- Rheumatic mitral valve disease
- Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
Detailed list of eligibility criteria
Principal Investigator
Jason Rogers, M.D.
Contact
Kaelyn Tuermer-Lee
916-734-5155
ktuermerlee@ucdavis.edu
MILLIPEDE
Full study name: A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation
Summary of trial: This study focuses on patients with functional mitral regurgitation, which occurs when the two mitral valve leaflets do not properly close. This results in blood leaking backwards through the valve and, in turn, causes the heart to have to pump harder. This study uses the Millipede System, an investigational device, and is delivered to the heart through a catheter. It is secured around the valve tissue in order to bring the valve opening back to normal size and open and close properly.
- Key inclusion:
- Moderate to severe (3+) or severe (4+) functional mitral regurgitation
- The local site heart team concurs that mitral valve surgery will not be offered as a first-line treatment option
- 18 years or older at time of consent
- Key exclusion:
- Participants with severe calcification of the mitral annulus or leaflets or other anatomic features that make the participant unsuitable for annuloplasty
- Transfemoral venous and transseptal access determined not to be feasible
- Participant is on the waiting list for a transplant or has had a prior heart transplant
Detailed list of eligibility criteria
Principal Investigator
Gagan Singh, M.D.
Contact
Kaelyn Tuermer-Lee
916-734-5155
ktuermerlee@ucdavis.edu
SUMMIT
Full study name: Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Summary of trial: This randomized study focuses on patients with moderate-to-severe or severe mitral regurgitation, which occurs when the two mitral valve leaflets do not properly close. This results in blood leaking backwards through the valve and, in turn, causes the heart to have to pump harder. This trail utilizes three cohorts: randomized, non-randomized, and Mitral Annular Calcification (MAC). The randomized cohort is a 1:1 ratio of getting the Tendyne Mitral Valve System, which is an investigational device to replace the valve entirely, or getting the MitraClip System, which is an FDA-approved device that clips the leaflets together. Subjects in the non-randomized and MAC cohorts receive the Tendyne Mitral Valve System. The purpose of this study is to evaluate the safety and effectiveness of the Tendyne Mitral Valve System to prevent mitral regurgitation.
- Key inclusion:
- Symptomatic, moderate-to-severe or severe mitral regurgitation where a transcatheter therapy is deemed more appropriate than open surgery by the local heart team
- The local site heart team determines that the subject has been adequately treated per applicable standards for coronary artery disease, left ventricular dysfunction
- 18 years or older at time of consent
- Key exclusion:
- Mitral valvular vegetation or mass
- Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
- Chest condition that prevents transapical access
Detailed list of eligibility criteria
Principal Investigator
Jason Rogers, M.D
Contact
Kimberley Book
916-734-5639
kabook@ucdavis.edu
TRILUMINATE
Full study name: Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal
Summary of trial: This randomized study focuses on patients with severe tricuspid regurgitation, which occurs when the tricuspid valve leaflets do not properly close. This results in blood leaking backwards through the valve and, in turn, causes the heart to have to pump harder. While some are treated for their tricuspid regurgitation using medical therapy, the investigational device called the TriClip to pinches the leaflets together and prevents the backflow of blood. This study consists of two arms: a randomized arm and a single arm. The randomized arm is either assigned to the TriClip device group or the control group (medical therapy) in a 1:1 ratio, whereas the single arm is assigned to the TriClip. The purpose of this study is to compare the investigational tricuspid valve repair system, the TriClip, plus standard of care drug therapy to standard of care drug therapy alone in order to reduce the effects of tricuspid regurgitation.
- Key inclusion:
- Participant has been adequately treated (including medical management) and stable for at least 30 days
- Participant is symptomatic with severe tricuspid regurgitation despite being optimally treated
- Participant is at intermediate or greater risk of mortality with tricuspid valve surgery as determined by cardiac surgeon
- 18 years or older at time of consent
- Key exclusion:
- Systolic pulmonary artery pressure > 70 mmHg or pre-capillary pulmonary hypertension as assessed by right heart catheterization
- Severe uncontrolled hypertension systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg
- Any prior tricuspid valve procedure that would interfere with placement of the TriClip device
Detailed list of eligibility criteria
Principal Investigator
Gagan Singh, M.D.
Contact
Kimberley Book
916-734-5639
kabook@ucdavis.edu
PROTECTED TAVR
Full study name: PROTECTED TAVR: Stroke Protection with Sentinel During Transcatheter Aortic Valve Replacement
Summary of trial: This randomized trial focuses on patients with severe aortic valve stenosis who are scheduled to undergo a transcatheter aortic valve replacement (TAVR). Aortic stenosis occurs when the opening of the aortic valve is narrowed, thereby restricting the blood flow through the valve and causing the heart to have to work harder. Participants getting the TAVR procedure to reduce aortic stenosis would be randomized to the Sentinel Cerebral Protection System (Sentinel) in a 1:1 ratio. Sentinel, a netting-like device, is meant to capture any embolic debris — such as blood clots, tissue, calcium — during the TAVR procedure. The purpose of the study is to see if there is any significant difference between the use of Sentinel and lack thereof in reducing the risk of stroke (≤ 72 hours) post-TAVR.
- Key inclusion:
- Participant has documented aortic valve stenosis and is treated with an approved transcatheter aortic valve replacement device via transfemoral access
- Participant has the recommended artery diameter at the site of filter placement per the Sentinel Cerebral Protection System Instructions for Use:
- 9-15 mm for the brachiocephalic artery
- 6.5-10 mm in the left common carotid artery
- Key exclusion:
- Participant has arterial stenosis > 70% in either the left common carotid artery or the brachiocephalic artery
- Participant has access vessels with excessive tortuosity
- Participant has uncorrected bleeding disorders
Detailed list of eligibility criteria
Principal Investigator
Jeffrey Southard, M.D.
Contact
Kaelyn Tuermer-Lee
916-734-5155
ktuermerlee@ucdavis.edu