Adult Cardiac

To evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.

Eligibility: The XVIVO Heart Preservation System (XHPS) is indicated for hypothermic non-ischemic oxygenated perfusion of excised donor hearts for preservation and transport to transplant. This device is intended to be used for extended criteria donor hearts with the intention of transplant into a recipient aged 18 or older.

Evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.

Eligibility: To be eligible for participating, a patient must have symptomatic, severe native aortic stenosis and be considered intermediate or low risk for surgical valve replacement.

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.

Eligibility: 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.

The APOLLO Trial is studying the safety and efficacy of an investigative device called the Intrepid Transcatheter Mitral Valve Replacement System. The Intrepid device is a heart valve that is designed to help alleviate mitral regurgitation so that blood can flow through your heart in the intended direction.

Eligibility: Patients with moderate-to-severe or severe symptomatic mitral regurgitation who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, may not be optimally treated with approved transcatheter repair or surgical mitral valve intervention.

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.

Eligibility: 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.

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.

Eligibility: Patients who already received transplants using donor hearts transported with the SherpaPak System, including children, adults, and older adults.

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.

Eligibility: 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.

This is an observational clinical study of LT patients that will evaluate the mechanistic impact of CFH on PGD.

Eligibility: 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.

Assess the safety and effectiveness of the ASG device in the treatment of lesions involving the ascending aorta and aortic arch.

Eligibility: Patients considered to be at high risk for open surgical repair who present with the following pathologies of the ascending aorta and aortic arch.

To compare the effect of percutaneous coronary intervention (PCI) vs coronary artery bypass grafting (CABG) on survival and improvement in quality-of-life (QOL) in women (RECHARGE:Women) and To compare the effect of PCI vs CABG on survival and improvement in QOL in patients who are either Black or Hispanic (RECHARGE:Minorities)

Eligibility: Adult patients (≥18 years) of female sex and/or Black race or Hispanic ethnicity with multivessel or left main coronary artery disease (CAD) intended for revascularization and for whom there is equipoise between CABG and PCI according to local Heart Team assessment

The primary objective of this registry is to capture the real-world data on the outcome of AtriCure Isolator® Synergy™ Surgical Ablation system (or future iterations) when used to ablate cardiac tissue in patients with Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS) using sinus node sparing hybrid ablation procedures. This is an observational, retrospective and prospective, multicenter, open-label patient registry.

Eligibility: The IST registry eligibility is open to sites and physicians performing the described treatments for patients diagnosed with IST and POTS. Subjects must have been scheduled to undergo or have undergone the described treatments for IST or POTS by their physicians and must meet all eligibility criteria in order for their treatment and results to be considered for this Registry.

The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US.

Eligibility: The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry.

GUARDIAN-Lung is a post-market, observational registry of adult and pediatric lung transplant recipient patients whose donor lung(s) was preserved and transported within the LUNGguard or the BAROguard. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria. Those patients will be compared to patients whose lung(s) were transported via other methods.

Eligibility: Retrospective primary lung transplant candidates will be screened for study eligibility. Eligible lung transplant candidates will be enrolled consecutively as they complete transplant at each site.

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR).

Eligibility: The J-Valve TF System is intended for treatment of symptomatic, severe, native AR and AR-dominant mixed aortic valve disease who are judged by a multi-disciplinary heart team to be at high risk for SAVR (defined as STS-PROM ≥8%, or if <8%, a documented heart team agreement determines that significant co-morbidities are not captured by the STS-PROM score).

Research study on how biometric data can be used to predict aortic events before and after aortic cardiac surgery.

Eligibility: Patients going through aortic cardiac surgery

To assess patient and caregiver perceptions of the quality and efficacy of discharge education given after cardiac surgery at Stanford Hospital

Eligibility: First time, on cardiopulmonary bypass, non-transplant cardiac surgery patients and their caregiver may be approached to participate in a 13-item survey and demographics questionnaire

The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US.

Eligibility: All lung transplant recipients who are transplanted with OCS perfused donor lung(s) will be enrolled in the registry.

To study the Carmat total artificial heart as a treatment for transplant-eligible patients in severe, end-stage heart failure

Eligibility: To be announced

Prospective, multicenter, non-randomized, single-arm study with two independent arms to sssess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.

Eligibility: Patients with de novo Type A aortic dissections

A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation

Eligibility: Patients who have been determined by the local heart team to have indication for and will benefit from aortic valve replacement and can be treated with both surgical AVR and Transcatheter AVR

This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.

Eligibility: The trial will include eligible heart transplant recipients, aged 18 years and older. Hearts from both donors after brain death (DBD) or donors after circulatory death (DCD)

Aim to generate algorithms from wearables biometric data to predict and guide management of post-transplant rejection

Eligibility: Patients who have had a heart transplant as well as control patients who have had open heart surgery other than heart transplant

To demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures

Eligibility: Adult subjects that are clinically indicated for a concomitant nsPFA procedure in addition to their primary cardiac surgery

The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve regurgitation (AR)

Eligibility: Adult patients on LVAD support with significant native AR

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.

Eligibility: Patients presenting with thoracic aortic disease who may benefit from the placement of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in Zone 0 or Zone 1

To evaluate the safety and effectiveness through assessment of primary graft dysfunction and patient and graft survival of the novel OCS Solution to support FDA approval. Also, this trial will evaluate the performance of the OCS Lung system with the novel OCS Solution compared to Static Cold Storage (SCS) in lung transplantation to potentially demonstrate superiority).

Eligibility: Patients on the lung transplant list who are eligible for the trial will have the trial explained to them, be invited to participate, and will be asked to sign an informed consent.

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.

Eligibility: Adult patients with aortic lesions who haven’t had previous repair surgeries

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

Eligibility:Patients ages 18-80 with acute DeBakey type I dissection and have presence of organ malperfusion (cerebral, visceral, renal, spinal cord, andperipheral).

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.

Eligibility: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.

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.

Eligibility: Patients enrolled in DT PAS (NCT03681210) are eligible for enrollment into Apogee and must be consented on the separate Apogee consent.

The purpose of this study is to collect data on short and long-term outcomes of the MITRIS RESILIA mitral valve in subjects requiring replacement of their native (original) or prosthetic (artificial) mitral valve.

Eligibility: Adult patients (18 years or older) diagnosed with mitral valve disease requiring a planned replacement of the native or prosthetic mitral valve. Concomitant coronary bypass surgery and ascending aorta resection and replacement from the sinotubular junction without the need for circulatory arrest were permitted.

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

Eligibility: All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System.

A prospective, randomized, controlled, multi-center study to establish the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in low risk patients who have severe, calcific, aortic stenosis requiring aortic valve replacement.

Eligibility: Patients with severe, calcific, aortic stenosis requiring aortic valve replacement who are at low operative risk

To establish the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis

Eligibility: Patients with asymptomatic, severe, calcific aortic stenosis and appropriate anatomy for transfemoral TAVR with the SAPIEN 3/SAPIEN 3 Ultra THV

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.

Eligibility: Patients with symptomatic functional and degenerative mitral regurgitation and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

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.

Eligibility: 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.

To demonstrate the effectiveness of LAA exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

Eligibility: Prospective, randomized, multicenter, multinational, blinded, superiority trial looking at patients 18 years of age or older, undergoing planned cardiac surgery, without documented clinical diagnosis of atrial fibrillation, who also present with documented risk factors for developing atrial fibrillation and ischemic stroke.

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.

Eligibility: 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

The primary objective of the IMPROVE-AD trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection

Eligibility: Patients diagnosed with a type B aortic dissection