Clinical Trials

We don’t just follow best practices, we define them

Research Background

Dr. Sheridan is renowned for his expertise in surgical approaches to the treatment of cardiovascular diseases. At California Pacific Medical Center, he serves as the Chief of Cardiothoracic surgery as well as Surgical Director of Heart Transplantation and Mechanical Circulatory Support. His clinical focus is the surgical treatment of high-risk and advanced heart failure patients.

This includes the review, selection and management of patients for reconstructive cardiac intervention, ventricular assist devices (durable or temporary) and/or heart transplantation. During his 14 years of educating the next generation of cardiothoracic residents, he served as Co-principal investigator on a National Institutes of Health sponsored research grant to examine optimal strategies for treating the elderly following myocardial infarction.

He helps lead surgical teams in advanced heart failure therapeutic trials, bringing notable clinical advances in ventricular assist devices and heart transplantation to patients in the Bay Area.

Primary research topics include:

  • Surgical treatment of high-risk and advanced heart failure patients.
  • Review, selection, and management of patients for reconstructive cardiac intervention, ventricular assist devices (durable or temporary) and/or heart transplantation.

Ongoing Trials (10)

Clasp IID To percutaneously treat Degenerative Mitral disease with Mitral Regurgitation

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Mitral Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

EXCEED To percutaneously treat intermediate risk patients with aortic stenosis

A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

SM3 To percutaneously severe MR requiring mitral valve repair or replacement who have high, but not prohibitive, operative risk

Early Feasibility Study of the Edwards Lifesciences SAPIEN M3 System for the Treatment of Mitral Regurgitation (MR)

Early TAVR To percutaneously treat patients with aortic stenosis

This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and outcome.

PARTNER 3 To percutaneously treat Aortic Stenosis (Low risk)

Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve.

EVOQUE To precutaneously treat mitral regurgitation

Early feasibility study to evaluate the safety and function of the Edwards EVOQUE transcatheter mitral valve replacement system

Intellect II-HF To improve the management of heart failure with a remote implantable pressure sensor in the setting of an LVAD.

The study is an observational, single group study, post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions, where all participants receive the same intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as standard of care. After enrollment into the study, the patient will be followed until six month follow up completion. The objective of this clinical investigation is to understand the role of hemodynamic monitoring in LVAD patients and:

  • Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients under different clinical and physiologic conditions
  • Characterize the effects of PA pressure on functional status, quality of life, and hospital readmissions of LVAD patients
  • Evaluate target ranges for PA pressure and assess the impact of medication and pump speed changes on PA pressures
Guide HF

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality. The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH).

Momentum 3 PAS

The main objective of this Post-Approval Study is to report the composite endpoint of survival to transplant, recovery, or LVAD support free of stroke or reoperation to replace the pump at 5-years post-implant in subjects who were implanted with the HM3 or HMII LVAS in the MOMENTUM 3 IDE trial and are ongoing at the 2-year follow-up.

Reprise IV

To evaluate safety and effectiveness of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Sets for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe aortic stenosis who are considered at intermediate risk for surgical valve replacement including those who have a bicuspid native valve.

Clinical Research Contributions (101)

March 2019

Left Atrial Septostomy as a Stress Test for Right Ventricular Function to Determine LVAD Candidacy.

March 2019

Pump Position Impacts HeartMate II Left Ventricular Assist Device Thrombosis.

April 2018

Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure.

2017

Hemodynamics of Left Ventricular Assist Device Implantation.

December 2017

Warfarin and Aspirin Versus Warfarin Alone for Prevention of Embolic Events in Patients with a HeartMate II Left Ventricular Assist Device.

February 2017

A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure.

November 2016

Prevention of HeartMate II Pump Thrombosis Through Clinical Management: The PREVENT multi-center study.

April 2016

Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

May 2015

Comparison of 30-Day Outcomes of Transfemoral Versus Transapical Approach for Transcatheter Aortic Valve Replacement: A Single-Center US Experience.

December 2014

Reduction in driveline infection rates: Results from the HeartMate II multicenter silicone-skin-interface (SSI) registry.

April 2014

Heartmate II inflow cannula migration does not predict late-term complications.

January 2014

A novel link between G6PD deficiency and hemolysis in patients with continuous-flow left ventricular assist devices.

August 2013

A left atrial mass in a middle-aged woman: Just another myxoma?

April 2013

Resource use trajectories for aged Medicare beneficiaries with complex coronary conditions.

April 2013

Disappearing and reappearing differences in drug-eluting stent use by race.

April 2013

Heartmate II inflow cannula position on chest x-ray predicts inotrope dependence.

February 2013

Emergency bedside thoracotomy.

December 2012

Strategies for multivessel revascularization in patients with diabetes.

November 2012

Stress imaging use and repeat revascularization among Medicare patients with high-risk coronary artery disease.

September 2012

Epidemiology, management, and outcomes of sustained ventricular arrhythmias after continuous-flow left ventricular assist device implantation.

August 2012

Evaluating the effectiveness of a rapidly-adopted cardiovascular technology with administrative data: The case of drug-eluting stents for acute coronary syndromes.

August 2012

Dynamic mitral regurgitation without regional wall motion abnormality.

April 2011

Myocardial viability and survival in ischemic left ventricular dysfunction.

April 2011

Coronary-artery bypass surgery in patients with left ventricular dysfunction.

March 2011

Improved outcome of surgical pulmonary embolectomy by aggressive intervention for critically ill patients

March 2011

Risk-benefit trade-offs in revascularisation choices.

November 2010

Laparoscopic splenectomy despite the presence of a left ventricular assist device.

June 2010

Three-year outcomes of multivessel revascularization in very elderly coronary syndrome patients.

June 2010

Accounting for heterogeneity in treatment selection: the case of revascularization.

2010

Coronary artery bypass surgery.

2010

Cardiac transplantation and mechanical circulatory support devices.

2010

Surgical treatment of valvular disease.

2010

Congenital coronary anomalies.

2010

Drug-eluting stents versus bare metal stents for Medicare beneficiaries with acute coronary syndromes: Instrumental variables compared to propensity scores.

November 2009

Contributions of extravascular and intravascular cells to fibrin network formation, structure and stability.

April 2009

Coronary bypass surgery with or without surgical ventricular reconstruction.

November 2008

Percutaneous coronary intervention or coronary artery bypass grafting: Intervention in older persons with Acute Coronary Syndrome – Part II.

October 2008

Percutaneous coronary intervention or coronary artery bypass grafting: Intervention in older persons with Acute Coronary Syndrome – Part I

2007

Outcomes of surgical and endovascular treatment of acute traumatic thoracic aortic injury.

2007

Off-pump insertion of continuous flow left ventricular assist devices.

2007

Use of the Jarvik 2000 continuous flow left ventricular assist device for acute myocardial infarction and cardiogenic shock.

2006

Surgical therapy for heart failure.

2006

Thrombin generation in vascular tissue.

2006

Differential effects of phosphodiesterase-5 inhibitors on hypoxic pulmonary vasoconstriction and pulmonary artery cytokine expression.

March 2006

Human degenerative valve disease is associated with upregulation of Lrp5 receptor mediated bone formation.

2005

Heart transplantation for progressive cardiomyopathy as a manifestation of MELAS syndrome.

2004

Energetics and hemodynamic changes of normal and various right heart bypass (Fontan) circulations in lambs under varying respiration parameters.

2004

Coronary artery bypass surgery, in Netter’s Cardiology.

2004

Cardiac transplantation, in Netter’s Cardiology.

2004

Congenital coronary anomalies, in Netter’s Cardiology.

2003

Lobar torsion complicating bilateral lung transplantation.

2003

So You’re Having Heart Bypass Surgery: Everything you need to know from diagnosis to recovery.

2000

Differential inducible nitric oxide synthase expression in systemic and pulmonary vessels after endotoxin.

1999

Independent and combined effects of inhaled nitric oxide, liquid perfluorochemical, and high- frequency oscillatory ventilation in premature lambs with respiratory distress syndrome.

1999

Independent and combined effects of inhaled nitric oxide, liquid perfluorochemical, and high-frequency oscillatory ventilation in premature lambs with respiratory distress syndrome.

1999

L-arginine treatment attenuates endothelial dysfunction in endotoxin-induced lung injury.

1999

Interleukin-11 attenuates pulmonary inflammation and vasomotor dysfunction in endotoxin-induced lung injury.

1999

Kinetics of Interleukin-11 release following cardiopulmonary bypass.

1999

L-arginine inhibits LPS-induced CINC protein production and lung neutrophil accumulation.

1999

GP 130-dependent signaling decreases endotoxin-induced pulmonary TNF-alpha and acute lung injury.

1998

L-arginine prevents lung neutrophil accumulation and preserves pulmonary endothelial function after endotoxin.

1998

L-arginine decreases alveolar macrophage proinflammatory monokine production during acute lung injury.

1998

Acute and chronic effects of bilateral lung transplantation without cardiopulmonary bypass on the first transplanted lung.

1998

Tissue specific PKC isoforms differentially mediate macrophage TNF alpha and IL-1beta production.

1998

Endotoxin differentially impairs receptor-mediated relaxation in rat isolated pulmonary and thoracic aortic vessels.

1997

Selective inhibition of receptor-mediated pulmonary vasorelaxation in endotoxin-induced acute lung injury.

1997

Endotoxin differentially impairs cyclic guanosine monophosphate-mediated relaxation in the pulmonary and systemic circulations.

1997

Effects of inhaled nitric oxide on pulmonary edema and lung neutrophil accumulation in severe experimental hyaline membrane disease.

1997

Hemorrhage induces acute cardioadaptation to ischemia-reperfusion by an alpha1-adrenoceptor-mediated, protein synthesis-independent mechanism.

1997

Pentoxyfilline attenuates pulmonary vasomotor injury.

1997

Phosphodiesterase inhibition overcomes pulmonary vasomotor dysfunction in acute lung injury.

1997

Protein Kinase C isoform diversity in preconditioning.

1997

Alpha-adrenergic activation of NF Kappa mediates hemorrhage-induced cardioadaptation to ischemia-reperfusion injury.

1997

LPS induces delayed cardiac protection against ischemia independent of myocardial and circulating TNF.

1997

KATP channels contribute to beat- and adenosine receptor -mediated pulmonary vasorelaxation.

1997

Surgical implications of vascular endothelial physiology.

1997

Endotoxin-induced vascular collapse derives from KATP channel activation with resultant impairment of alpha1-adrenergic signaling.

1997

P38 MAP kinase mediates myocardial ischemia-reperfusion injury: Improved post-ischemic recovery with SB 203580 (Cytokine suppressor anti-inflammatory drug; CSAID)

1997

Surgical implications of vascular endothelial physiology.

1997

Hemorrhage activated myocardial NFkB and increases tumor necrosis factor in the heart.

1996

Antibody-mediated neutrophil depletion preserves pulmonary vasomotor function.

1996

Microtubules regulate pulmonary vascular smooth muscle contraction.

1996

Endotoxin stuns cGMP-mediated pulmonary vasorelaxation.

1996

Neutrophils are required for endotoxin-induced myocardial cross-tolerance to ischemia-reperfusion injury.

1996

Impairment of endothelial-dependent pulmonary vasorelaxation after mesenteric ischemia/reperfusion.

1996

Neutrophil-depletion attenuates dysfunction of cGMP-mediated pulmonary vasorelaxation in endotoxin-induced lung injury.

1996

The obligate role of protein kinase C in mediating clinically accessible cardiac preconditioning.

1996

Vinblastine attenuates endotoxin-induced impairment of cGMP-mediated pulmonary vasorelaxation.

1996

Magnesium is essential in mechanisms of pulmonary vasomotor control.

1996

Cardiac preconditioning with calcium: Clinically accessible myocardial protection.

1996

Protein kinase C mediates Ca2(+) induced cardioadaptation to ischemia-reperfusion injury.

1996

Inhaled nitric oxide prevents pulmonary endothelial dysfunction after mesenteric ischemia-reperfusion.

1996

Ischemic preconditioning in human and rat ventricle.

1996

The alpha and beta isoforms of protein kinase C mediates the cardiac contractile response to exogenous calcium.

1996

Neutrophils mediate vascular smooth muscle dysfunction in acute lung injury.

1996

Cardiac surgical implications of calcium dyshomeostasis in the heart.

Adenosine preconditioning of human myocardium is mediated through KATP channel activation.

1996

1996

Neutrophils mediate pulmonary vasomotor dysfunction in endotoxin-induced acute lung injury.

1996

Differential effects of adenosine preconditioning on the post-ischemic rat myocardium.

1993

The surgical anatomy of the principal nutrient vessel of the tibia.

1988

Anesthetic and hemodynamic effects of the stereoisomers of medetomidine, an alpha 2-adrenergic agonist, in halothane-anesthetized dogs.

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