Clinical Trials
What Are Clinical Trials?
Clinical trials are medical research where doctors use experimental new drugs or treatments on patients. The treatments have not been conclusively proven safe and effective, but they are only approved for testing on patients if the evidence to date suggests that they are.
Cardiothoracic surgery is changing quickly, as surgeons find ways to repair the heart and lungs through smaller incisions and often in older patients. Stanford pioneers many of these new approaches. Sometimes we serve as one of several sites in a national or regional clinical trial. We also host clinical trials led by our own faculty members.
The following trials are underway and open to new patients. If you are interested in participating, talk to your doctor.
But first check out our promise to you
if you participate in our trials.
Medtronic Pericardial Surgical Aortic Valve Replacement Pivotal Trial, or PERIGON
This trial is evaluating the long-term safety and effectiveness of the Model 400 Aortic Valve Biological Prosthesis in patients who require replacement of the aortic valve.
Who might be eligible: Adults with moderate to severe aortic stenosis who are indicated for valve replacement
How long the study will last: Up to 5 years
Study Lead: Michael Fischbein, MD, Stanford University
Medtronic Pericardial Surgical Aortic Valve Replacement
HeartMate 3 Left Ventricular Assist System as a Bridge to Transplant
This study evaluates whether the HeartMate 3 Left Ventricular Assist System works at least as well as the previous model, HeartMate II LVAS, to treat advanced left ventricular heart failure that isn’t well managed by other treatments.
Who might be eligible: Adults with symptomatic heart failure
How long the study will last: Up to 2 years
Study Lead: Richard-Tien Van Ha, MD, Stanford University
HeartMate 3 Left Ventricular Assist System
HeartAssist 5 Ventricular Assist Device as a Bridge to Transplant
This study evaluates the safety and effectiveness of the HeartAssist 5 VAD System as a treatment to support patients waiting for heart transplant by comparing it to the FDA-approved devices Thoratec HeartMate II VAD and HeartWare HVAD.
Who might be eligible: Adults with end-stage heart failure who are approved for LVAD implantation
How long the will last: Up to 2 years
Study Lead: Richard-Tien Van Ha, MD, Stanford University
HeartWare Implanted HVAD® Pump
Stem Cells to Treat Heart Failure
This trial evaluates the safety and efficacy of injecting stem cells called mesenchymal precursor cells into the heart muscle in patients with left ventricular assist devices (LVADs). The purpose is to see whether the stem cells can help ease heart failure in patients and how exactly they do so.
Who might be eligible: Adults with end-stage heart failure (from any cause), who are being evaluated for LVAD implantation.
How long the study will last: Up to 1 year
Study Lead: Joseph Woo, MD, Stanford University
Reducing Stroke Risk in Patients with Atrial Fibrillation
This study investigates whether closing the small pouch at the top of the heart, called the left atrial appendage, can reduce the risk of stroke in patients with a history of atrial fibrillation. The left atrial appendage is present in everyone, but the irregular heart rhythm in atrial fibrillation may cause blood clots to form in it. The clots can travel through the bloodstream leading to stroke or injury to other organs. This study compares rates of ischemic stroke or transient ischemic attack in patients who have the LAA closed during surgery to rates among patients who undergo similar surgeries without having the LAA closed.
Who might be eligible: Adults with atrial fibrillation for whom heart surgery with the use of the cardiopulmonary bypass machine is recommended
How long the study will last: About 4 years
Study Lead: Anson Lee, MD, Stanford University
GORE TAG Thoracic Branch Endoprosthesis to Treat Aortic Lesions
This study will explore whether the GORE TAG Thoracic Branch Endoprosthesis, similar to a stent, can be used to repair disease and injury to the aortic arch and/or the descending thoracic aorta.
Who might be eligible: Adult patients with aortic lesions who haven’t had previous repair surgeries
How long the study will last: Up to 4 years
Study Lead: Michael Fischbein, MD, Stanford University
GORE TAG Thoracic Branch Endoprosthesis
UPCOMING TRIALS
We are seeking participants for several clinical trials we’re about to launch. If you are interested in participating, please talk to your doctor. But first check out our promise to you if you participate in our trials.
Shockwave Medical Peripheral Lithoplasty System Study for PAD, or Disrupt PAD III
This study assesses whether it is safe and effective to use lithoplasty, rather than standard balloon angioplasty, with a drug-coated balloon to treat peripheral artery disease (PAD) that affects femoral or popliteal arteries.
Who Might Be Eligible: Adults with moderate to severe peripheral artery disease who have not experienced tissue loss and do not have surgery scheduled on the affected limb
How long the study will last: 2 years
Study Lead: Michael Dake, MD
Shockwave Medical Peripheral Lithoplasty System
MANTA Vascular Closure Device Clinical Study, or MANTA
This study explores whether using the MANTA device to close the catheter insertion site after transcatheter interventional procedures such as transcatheter aortic valve replacement (TAVR) and endovascular aneurysm repair (EVAR) improves clinical outcomes for patients.
Who Might Be Eligible: Adults undergoing a transcatheter procedure like those above in which the catheter is inserted through the femoral artery
How long the study will last: 60 days
Study Lead: Michael Dake, MD
MANTA Vascular Closure Device
Harmony Transcatheter Pulmonary Valve Trial
This clinical trial examines whether the Medtronic Harmony prosthetic pulmonary valve can safely improve heart function when inserted through a catheter.
Who Might Be Eligible: Patients with congenital heart disease and pulmonary regurgitation who are clinically indicated for pulmonary valve replacement, with no pre-existing prosthetic heart valve or ring
How long the study will last: 5 years
Study Lead: Doff McElhinney, MD
Harmony Transcatheter Pulmonary Valve
Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention (PCI)
This trial will evaluate whether combining minimally invasive coronary artery bypass surgery with the use of drug-eluting stents can provide better results than the use of the stents alone to treat multi-vessel coronary artery disease (CAD).
Who Might Be Eligible: Adults with multi-vessel CAD involving the left anterior descending and/or left main arteries
How long the study will last: 5 years
Study Lead: Joseph Woo, MD
Thoraflex Hybrid Device to Repair or Replace the Thoracic Aorta
This trial evaluates the safety and effectiveness of the Thoraflex Hybrid Device, which includes graft and stents, in treating a ruptured aorta or damaged aortic arch and descending aorta.
Who might be eligible: Adult patients with acute or chronic dissection of the aorta
How long the study will last: 3 years
Study Lead: Michael Fischbein, MD, Stanford University
Thoraflex Hybrid Device
"MOMENTUM 3" Trial of HeartMate 3 Left Ventricular Assist System
This study will track the safety and effectiveness of the HeartMate 3 Left Ventricular Assist System (LVAS) in patients who have advanced, treatment-resistant left ventricular heart failure and are referred for LVAS implantation surgery.
Who might be eligible: Adults with advanced left ventricular heart failure
How long the will last: Up to 2 years
Study Lead: Richard-Tien Van Ha, MD, Stanford University
HeartMate 3 Left Ventricular Assist System
Studying Concurrent Tricuspid Valve Repair During Mitral Surgery
The purpose of this trial is to determine whether patients, who are undergoing surgery to treat mitral valve regurgitation and also have mild to moderate tricuspid regurgitation, will benefit from concurrent tricuspid valve repair.
Who might be eligible: Adult patients with degenerative mitral regurgitation
How long the study will last: Up to 2 years
Study Lead: Joseph Woo, MD, Stanford University
NeoChord DS1000 System
The objective of this trial is to assess the safety and effectiveness of the NeoChord DS1000 minimally invasive system to replace the chordae in mitral valve repair surgeries without cardiopulmonary bypass, by comparing those patients’ outcomes to those of patients who undergo standard mitral valve repair surgeries with chordae replacement while on cardiopulmonary bypass.
Study Lead: Joseph Woo, MD, Stanford University
NeoChord DS1000
Portable Organ Care System (OCS) to Improve Availability of Donor Lungs for Transplant
The purpose of this trial is to evaluate whether use of the portable Organ Care System, which cools, ventilates and circulates blood through donor organs in transit, can make donor lungs viable for a longer window and/or improve clinical outcomes of patients who receive lungs transported this way.
Study Lead: Anson Lee, MD, Stanford University
Portable Organ Care System
The following trials are under way but not currently seeking patients:
"COMMENCE" Aortic & Mitral Bioprostheses Study
The objective of this trial is to confirm that the new methods of tissue processing, valve sterilization, and packaging for the latest models of Edwards bioprosthetic valves (the Edwards Pericardial Aortic Bioprosthesis Model 11000A and the Edwards Pericardial Mitral Bioprosthesis Model 11000M) do not raise new questions of safety or effectiveness over previous FDA-approved models. Bioprosthetic heart valves are used in patients with valvular heart disease who cannot safely take long-term anticoagulation medication.
Study Lead: Craig Miller, MD, Stanford University
Edwards bioprosthetic valve
"TRANSFORM" Rapid Deploy Aortic Valve Replacement Study
This trial assesses the safety and effectiveness of the Edwards INTUITY Valve System in patients with aortic valve disease. The device is designed to reduce the implant time by using only three sutures to put the valve in place. Data suggests that less time on cardiopulmonary bypass reduces the risk of complications.
Study Lead: Joseph Woo, MD, Stanford University
EDWARDS INTUITY Elite
Prosthetic Arteries to Treat Aortic Arch Aneurysms
This is an early-stage study to assess whether the GORE TAG Thoracic Branch Endoprosthesis can be used to treat aneurysms on the aortic arch. Surgeons will evaluate whether they can successfully deploy the Branched TAG Device and verify their success with angiography at the conclusion of the procedure.
Study Lead: Michael Fischbein, MD, PhD, Stanford University
GORE TAG Thoracic Branch Endoprosthesis
Gore TAG Thoracic Branch Biological Patch to Repair Aortic Arch and Descending Thoracic Aorta Injuries
This study will explore whether the medical device called the GORE TAG Thoracic Branch Endoprosthesis can be used to repair aortic diseases and injuries that affect the aortic arch and/or the descending thoracic aorta.
Study Lead: Michael Fischbein, MD, PhD, Stanford University
GORE TAG Thoracic Branch Endoprosthesis
Prosthetic Arteries to Treat Type B Aortic Dissection
This study explores whether the GORE TAG Thoracic Branch Endoprosthesis works as a stent graft to treat complicated dissections of the descending thoracic aorta. No endovascular stent graft is currently approved to treat acute complicated type B aortic dissection in the United States, and patients with this dissection could benefit from minimally invasive treatment options.
Study Lead: Michael Dake, MD, Stanford University
GORE TAG Thoracic Branch Endoprosthesis
Filters to Prevent Dangerous Blood Clots
This research explores whether the Sentry Inferior Vena Cava (IVC) Filter can be placed safely in a vein in the inferior vena cava to filter blood for any clots that may occur. The Sentry IVC Filter is intended to prevent blood clots from moving through the body to the lungs in patients who are at risk but cannot safely take anti-coagulant medications.
Study Lead: Michael Dake, MD, Stanford University
Sentry Inferior Vena Cava (IVC) Filter
Drug-Eluting Balloons to Treat Arterial Blockages
This trial assesses the safety and efficacy of the IN.PACT Admiral Paclitaxel-eluting Percutaneous Transluminal Angioplasty Balloon Catheter as compared to standard “balloon” treatment (also called PTA), for un-stented recurring blockages in the superficial femoral artery and the proximal popliteal artery.
Study Lead: Michael Dake, MD, Stanford University
IN.PACT Admiral Paclitaxel-eluting Percutaneous Transluminal Angioplasty Balloon Catheter
We will always provide you with the best known care for your illness.
We do not ask patients to do without standard treatment for their condition. We use experimental treatments in addition to the best available care, or on patients who haven’t responded to standard care.
We will never give you treatments we know are unsafe.
The treatments in clinical trials have not yet been proven safe. But we test them in stages, beginning with lab tests and animal studies, before giving them to small groups of people. If the evidence suggests they are unsafe, we stop using them.
We will keep your personal information private.
The law requires us to maintain your privacy, and we take that obligation very seriously.
What we can't promise
The treatments we're testing are still being studied. We cannot yet guarantee that they are safe and effective.
We also can't promise that you’ll get the experimental treatment. Some patients get placebos because a control group is necessary for our studies to be scientifically valid. If you believe an experimental drug is your last option for a life-threatening disease, your best option may be to petition the Food and Drug Administration for "compassionate use."
Explore your options
There is a lot of information available about clinical trials. We encourage you to do research on your own and discuss your options with family members and doctors.
ClinicalTrials.gov lists all of the ongoing clinical trials in the United States. The information can be very scientific, but it is a good place to start to build a list of questions for your doctors.