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.

Open Trials

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: William Hiesinger, MD

More information on ClinicalTrials.gov

HeartWare Implanted HVAD® Pump

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

More information on ClinicalTrials.gov

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

More information on ClinicalTrials.gov

GORE TAG Thoracic Branch Endoprosthesis

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

More information on ClinicalTrials.gov

Shockwave Medical Peripheral Lithoplasty System

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

More information on ClinicalTrials.gov

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

More information on ClinicalTrials.gov

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: William Hiesinger, MD

More information on ClinicalTrials.gov

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

More information on ClinicalTrials.gov

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.

Who might be eligible: Patients with moderate to severe degenerative mitral valve regurgitation, isolated mitral valve prolapse, and are a candidate for mitral valve repair without cardiopulmonary bypass

How long the study will last: 5 years

Study Lead: Joseph Woo, MD

More information on ClinicalTrials.gov

NeoChord DS1000

Upcoming Trials

Edwards Cardioband System ACTIVE Pivotal Clinical Trial

The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically significant functional mitral regurgitation will be randomized 2:1 to receive either transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) or GDMT alone.

Who might be eligible: Patients with clinically significant functional mitral regurgitation (MR) and symptomatic heart failure

How long the study will last: 5 years

Study Lead: Joseph Woo, MD

More information on ClinicalTrials.gov

Edwards Cardioband

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation – APOLLO Trial

The APOLLO Trial is a multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device.

Who might be eligible: Patients with severe, symptomatic mitral regurgitation and are a candidate for bioprosthetic mitral valve replacement

How long the study will last: 5 years

Study Lead: Joseph Woo, MD

More information on ClinicalTrials.gov

Medtronic Intrepid™ TMVR  

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

More information on ClinicalTrials.gov

Harmony Transcatheter Pulmonary Valve

Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation (OCS EXPAND II)

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.

Who might be eligible: Patients who are primary double lung transplant candidates

How long the study will last: 3 years

Study Lead: Anson Lee, MD

More information on ClinicalTrials.gov

Portable Organ Care System

The following trials are under way but not currently seeking patients:

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.

Study Lead: William Hiesinger, MD

More information on ClinicalTrials.gov

HeartMate 3 Left Ventricular Assist System

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.    

Study Lead: Joseph Woo, MD

More information on ClinicalTrials.gov

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.

Study Lead: Michael Dake, MD

More information on ClinicalTrials.gov

MANTA Vascular Closure Device

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.

Study Lead: Michael Fischbein, MD

More information on ClinicalTrials.gov

Medtronic Pericardial Surgical Aortic Valve Replacement

"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

More information on ClinicalTrials.gov

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

More information on ClinicalTrials.gov

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

More information on ClinicalTrials.gov

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

More information on ClinicalTrials.gov

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

More information on ClinicalTrials.gov

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

More information on ClinicalTrials.gov

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

More information on ClinicalTrials.gov

IN.PACT Admiral Paclitaxel-eluting Percutaneous Transluminal Angioplasty Balloon Catheter

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.

Questions?