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
Last updated: February 2023
The ReChord Trial: Randomized Trial of the NeoChord DS1000 System versus Open Surgical
Repair
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).
Who might be eligible: Patient intended to undergo mitral valve repair with cardiopulmonary bypass
Study Duration: 5 Years
Study Lead: Jack Boyd, MD
NeoChord DS1000
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation.
Who might be eligible: Adults with degenerative mitral regurgitation (DMR)
Study Duration: Approximately 5 years
Study Lead: William Hiesinger, MD
Edwards PASCAL Transcatheter Mitral Valve Repair System
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
Study Duration: 5 years
Study Lead: Jack Boyd, MD
Medtronic Intrepid™ TMVR
Medtronic Terminate AF Study
The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex handheld devices to support an indication expansion to include treatment of non-paroxysmal atrial fibrillation to the product labeling.
Who might be eligible: Adults with non-paroxysmal AF (persistent or longstanding persistent atrial fibrillation)
Study Duration: Approximately 5 years
Study Lead: Anson Lee, MD
Cardioblate CryoFlex 7cm Probe
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
Study Duration: Up to 4 years
Study Lead: Michael Fischbein, MD
GORE TAG Thoracic Branch Endoprosthesis
Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery (REPAIR-MR)
The purpose of this research study is to assess the clinical effectiveness of the MitraClip™ system for treating patients who are candidates for Mitral Valve (MV) repair surgery, with the intent to expand the indication for MitraClip™. The MitraClip™ system will be compared against MV repair surgery which is the current standard of care for patients with Primary Mitral Regurgitation (MR) who are candidates for mitral valve surgery.
Who might be eligible: Patients ages 18 and older who: have severe primary mitral regurgitation (MR), candidate of both the MitraClip™ device and MV repair surgery, are symptomatic or asymptomatic with LVEF ≤ 60%, pulmonary artery pressure systolic pressure > 50 mmHg, or LVESD > 40 mm, and are at moderate surgical risk.
Study Duration: 10 Years
Study Lead: John MacArthur, MD
A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS™ Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch: TRIOMPHE Study
The purpose of this study is to evaluate the safety and effectiveness of the NEXUS™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic lesions involving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers and intramural hematoma.
Who might be eligible: Patients ages 18 and older who have been diagnosed with one of the following: chronic aortic arch dissection, aortic arch aneurysm, penetrating aortic ulcer, aortic intramural hematoma.
Study Duration: 5 Years
Study Lead: Amelia Claire Watkins, MD
NEXUS™ Aortic Arch Stent Graft System
The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation
The purpose of this study is to collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™ Lung System in lung transplantation from
standard criteria donors and donors initially deemed unacceptable for procurement and transplantation due to the limitations of cold static preservation.
Who might be eligible: All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System.
Study Duration: 5 Years
Study Lead: Anson Lee, MD
OCS™ Lung System
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG (PACeS)
The overall objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.
Who might be eligible: Patients at least 18 years of age undergoing isolated coronary artery bypass grafting (CABG) surgery for coronary artery disease (CAD), and experiencing postoperative atrial fibrillation (POAF) that persists for >60 minutes or is recurrent within 7days after the CABG surgery.
Study Duration: Approximately 6 months
Study Lead: Jack Boyd, MD
CentriMag Failure-to-Wean Post-Approval Study
The primary objective of this PAS is to report the proportion of patients surviving to 30 days post CentriMag support or to hospital discharge, whichever is longer. For subjects who do not recover and are bridged to a heart transplant or a long-term assist device, the primary endpoint is survival to induction of anesthesia for the surgery.
Who might be eligible: Patients who are 18 years and older and have a CentriMag Circulatory Support System implanted due to fail-to-wean (FTW) from cardiopulmonary bypass (CPB).
Study Duration: 30 days or until discharge
Study Lead: William Hiesinger, MD
CentriMag Circulatory Support System
A Prospective, Single Arm, Multi-center Clinical Investigation to Evaluate the Safety and Effectiveness of the Ascyrus Medical Dissection Stent (AMDS) in the Treatment of Acute DeBakey Type I Dissection (PERSEVERE)
A Prospective, Single Arm, Multi-center Clinical Investigation to Evaluate the Safety and Effectiveness of the Ascyrus Medical Dissection Stent (AMDS) in the Treatment of Acute DeBakey Type I Dissection
Who might be eligible: Patients ages 18-80 with acute DeBakey type I dissection and have presence of organ malperfusion (cerebral, visceral, renal, spinal cord, andperipheral).
Study Duration: 5 Years
Study Lead: Amelia Claire Watkins, MD
Global Utilization and Registry Database for Improved Heart Preservation (GUARDIAN)
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor hearts that were preserved and transported within the SherpaPak Cardiac Transport System, as well as retrospective standard of care patients.
Who might be eligible: Patients who already received transplants using donor hearts transported with the SherpaPak System, including children, adults, and older adults.
Study Duration: 1 Year
Study Lead: Yasuhiro Shudo, MD
SherpaPak Cardiac Transport System
Upcoming Trials
CTSN PRIMARY
The PRIMARY Study is a prospective, multicenter, open-label, randomized trial comparing MV transcatheter edge-to-edge repair to surgical repair (1:1 ratio) in patients with primary, degenerative MR.
Who might be eligible: Patients 65 years or older with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible.
Study Duration: 10 years
Principal Investigator: Jack Boyd, MD
Atricure HEAL-IST
The HEAL-IST Study is a prospective, multi-center, single arm, Bayesian Adaptive Design, IDE trial evaluating the safety and effectiveness of a hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System for the treatment of symptomatic drug refractory or drug intolerant IST.
Who might be eligible: Subjects who have symptomatic IST but are refractory or intolerant to rate control drugs (e.g., beta-blockers/calcium channel blockers, ivabradine), and/or AADs.
Principal Investigator: Anson Lee, MD
Perioperative Factors That Drive Cell-free Hemoglobin-Mediated Primary Graft Dysfunction
This is an observational clinical study of LT patients that will evaluate the mechanistic impact of CFH on PGD.
We are evaluating how the build-up of cell-free hemoglobin (CFH) in the lungs and bloodstream may contribute to injury to the newly transplanted lung. One type of lung injury is called primary graft dysfunction (PGD). PGD happens within 72 hours after transplant in 10-30% of lung transplant (LT) recipients. Patients who develop severe PGD have higher risk of rejection and chronic lung allograft dysfunction (CLAD). Our goal is to understand what causes PGD so that we can develop new treatments to prevent this complication of lung transplant.
Principal Investigator: John MacArthur, MD
CARMAT Aeson Study
To study the Carmat total artificial heart as a treatment for transplant-eligible patients in severe, end-stage heart failure
Principal Investigator: William Hiesinger, MD
Gore ARISE II
The Evaluation of the GORE Ascending Stent Graft (ASG device) in the treatment of Lesions of the Ascending Aorta.
Assess the safety and effectiveness of the ASG device in the treatment of lesions involving the ascending aorta and aortic arch.
Who might be eligible: Patients considered to be at high risk for open surgical repair who present with the following pathologies of the ascending aorta and aortic arch.
Study Duration: 5 Years
Principal Investigator: Amelia Claire Watkins, MD
The following trials are under way but not currently seeking patients:
Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial): A Phase 1/2 Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Efficacy
The purpose of this study is study to determine the safety of the Investigational Product called XC001 in human research subjects suffering from angina caused by coronary artery disease who have no other treatment options.
Who might be eligible: Patients ages 18 to 80 who: have been diagnosed with chronic angina due to obstructive coronary artery disease that is refractory to drug therapy and unsuitable for revascularization, angina class II-IV, and
adequate hematologic, hepatic, and renal function.
Study Duration: Approximately 13.5 months
Study Lead: Juyong Brian Kim, MD
Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study (ARIES HM3)
The purpose of this research study is to evaluate the regimen of blood-thinning medications taken by patients with advanced heart failure treated with the HeartMate 3™ LVAD.
Who might be eligible: Advanced heart failure patients being treated with the HeartMate 3 Left Ventricular Assist System (LVAS).
Study Duration: Up to 3 Years
Study Lead: William Hiesinger, MD
Destination Therapy Post Approval Study (DT PAS)
Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice.
Who might be eligible: Patients intended to be implanted with a HVAD for use as a destination therapy are eligible for enrollment into the DT PAS and must be consented for the PAS prior to the HVAD implant.
Study Duration: Approximately 5 years
Study Lead: William Hiesinger, MD
HeartWare HVAD
Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy.
Who might be eligible: Patients enrolled in DT PAS (NCT03681210) are eligible for enrollment into Apogee and must be consented on the separate Apogee consent.
Study Duration: 12 Months
Study Lead: William Hiesinger, MD
HeartWare HVAD
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on
Preconditioning Response Biomarkers in Subjects Undergoing Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery (The START Study)
This study is being performed to see whether RBT-1, an investigational new drug, can increase proteins (biomarkers)
in the body that are associated with protecting organs from injury. This study will enroll patients who are undergoing non-emergent coronary artery bypass graft (CABG) and/or cardiac valve surgery requiring cardiopulmonary bypass (heart-lung machine) and who have risk factors for kidney injury.
Who might be eligible: Patients ages 18 and older who: have stable kidney function and no epidosdes of AKI four weeks prior to to undergoing non-emergent coronary and/or valve surgery(ies) requiring cardiopulmonary bypass.
Study Duration: 3 Months
Study Lead: John MacArthur, MD
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?
Contact us at ctsurgeryresearch@stanford.edu