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The Division of Cardiac Surgery is internationally respected by other heart experts for participating in, and leading, clinical trials that advance surgical treatment of heart disease and provide options for patients for whom traditional surgical solutions are not an option.

Aortic Vascular Studies

TBE

Prospective, non-randomized, multicenter study with four independent arms consisting of a total of seven cohorts.

This study will determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Participants in this study will be treated with the GORE TAG Thoracic Branch Endoprosthesis Device

Relay Pro-D

A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects with an Acute, Complicated Type B Aortic Dissection

The purpose of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with an acute, complicated type B aortic dissection.

Participants in this study will be treated with the RelayPro Thoracic Stent-Graft System

ARISE

Prospective, multicenter, non-randomized, single arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft

This study will assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft

Participants in this study will be treated with the GORE Ascending Stent Graft

  • Principal Investigators Dr. Bradley Taylor & Dr. Shahab Toursavadkohi

RelayBranch

A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System in Subjects with Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery

The purpose of this study is to conduct an early clinical evaluation of the RelayBranch System, which will provide initial insight into the clinical safety and function of the device. This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. The data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.

Participants in this study will be treated with the RelayBranch Thoracic Stent-Graft System

TRIOMPHE

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

This study will 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.

Participants in this study will be treated with the NEXUS™ Aortic Arch Stent Graft System.

FRAME

Prospective, multicenter study evaluating the performance and safety of FRAME, External Support for lower limb autologous grafts.

This study will confirm clinical performance, usability, and safety, of the FRAME when used according to its Instructions for Use. The study intends to assess patency rates of FRAME supported bypass grafts and associated risks.

Participants in this study will be treated with the FRAME External Support

Mitral Valve Studies

APOLLO

Multi-center, global, prospective, interventional, pre-market trial. Enrolled subjects will be assigned to Transcatheter Mitral Valve Replacement (TMVR) with the Medtronic Intrepid™ TMVR System

This trial will evaluate the safety and efficacy of the Medtronic Intrepid™ TMVR System in patients with moderate-to-severe or severe symptomatic mitral regurgitation who may not be optimally treated with approved transcatheter repair or surgical mitral valve intervention.

Approved participants in this study will receive the Medtronic Intrepid™ TMVR System

RESTORE

A prospective, multi-center trial to evaluate the safety and effectiveness of beating heart mitral valve repair with the HARPOON™ System (RESTORE)

This study will evaluate the safety and effectiveness of the HARPOON System in the
treatment of patients with severe degenerative mitral regurgitation.

Patients with severe Degenerative Mitral Regurgitation (DMR) will receive the HARPOON Beating Heart Mitral Valve Repair System (HARPOON System).

SUMMIT

Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, moderate-to-severe or severe mitral regurgitation or severe mitral annular calcification (MAC) for whom the heart team deems transcatheter treatment is more appropriate than conventional mitral valve surgery.

This study will evaluate the safety and effectiveness of the Tendyne Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

Participants will receive either the Tendyne Mitral valve system or Mitraclip system depending on their heart anatomy.

Tricuspid Valve Studies

TRISCEND Early Feasibility Study & TRISCEND II

A prospective, single-arm, multi-center, early feasibility study (EFS) to evaluate the safety and performance of the EVOQUE system in the treatment of patients with at least moderate Tricuspid Regurgitation (TR), signs of TR, symptoms from TR, or prior heart failure hospitalizations for TR.

This study will evaluate the safety and performance of the EVOQUE system, provide guidance for future clinical study designs utilizing the EVOQUE system, and provide guidance for future EVOQUE system development efforts

The EVOQUE system is intended for the treatment of patients with at least moderate tricuspid regurgitation (TR) or prior heart failure hospitalization for TR.

CLASP II

A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation

This study will evaluate the safety and effectiveness of the PASCAL System for transcatheter tricuspid valve repair with OMT compared to OMT alone in the treatment of patients with symptomatic severe tricuspid regurgitation.

Eligible patients will receive optimized medical treatment and will be randomized to treatment with the PASCAL device or to receive medical treatment alone.

Atrial Fibrillation Studies

ICE-AFIB

A prospective, multicenter, single arm, Bayesian Adaptive Design pivotal study

The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.

Study participants will have their Cox-Maze III lesion set performed by the AtriCure CryoICE system in conjunction with LAA exclusion using the AtriClip device.

PACeS

Prospective, multicenter, open-label, randomized trial comparing oral anticoagulation (OAC) with no OAC (1:1 ratio) in patients who develop new-onset post-operative atrial fibrillation after coronary artery bypass graft.

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 new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.

This is an observational study and participants will be randomized to either receive oral anticoagulation (OAC) with background antiplatelet therapy or an antiplatelet alone

NOVA

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN-151607) Injections into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery

This study will compare the efficacy of AGN-151607 with placebo to prevent post-operative atrial fibrillation (POAF) in participants who are undergoing open-chest cardiac surgery

Participants will be randomized to either receive botulinum toxin type A (AGN-151607) or placebo to prevent operative atrial fibrillation

COVID-19 Trials

RECOVER

A Phase I, double-blinded, randomized, placebo-controlled study to test the safety of LMSCs in Adults suffering from mild to severe acute respiratory distress syndrome (ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant from influenza virus infection

This study will evaluate the regenerative Medicine Approach for COVID-19 and Influenza Virus-Elicited Acute Respiratory Distress Syndrome (ARDS) Using Longeveron Mesenchymal Stem Cells (LMSCs)

Eligible participants will be randomized to receive Longeveron Mesenchymal Stem Cells or a placebo.

ACTIV-3 TICO

A multi-center, adaptive randomized, blinded controlled trial of the safety and efficacy of investigation therapeutics for hospitalized patient with COVID-19

This study will evaluate the efficacy of multiple investigation agents aimed at modifying the host immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or directly enhancing viral control in order to limit disease progression

Participants will be randomized to receive BRI-196/ BRI- 198, VIR-7831, AZD7442 or placebo to modify the host immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or directly enhancing viral control in order to limit disease progression.

 

Lung Transplant

BOSTON 1 & 2

A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single or double Lung Transplantation"

The objective of the trial is to assess the efficacy and safety of add-on aerosolized L-CsA to Standard of Care therapy as compared to SoC therapy alone in the treatment of BOS in single and double lung transplant recipients.

Patients randomized to L-CsA treatment will receive L-CsA inhalation therapy in addition to standard of care treatments

Aim 1 - Regadenoson

Design: A phase I, open label study to evaluate adenosine 2A receptor agonist (Regadenoson) in patients undergoing lung transplantation

Objectives: Determine the optimal dose and infusion duration of Regadenoson that is safe in human lung transplant recipients. Facilitate the development of a randomized multi-center study.

Subjects will receive Regadenoson for 12 hours starting at the time of transplant.

EVP-DEX-LTX-301

This is a prospective, multicenter, un-blinded, non-randomized study evaluating the safety and effectiveness of the CLES.

The study will evaluate the safety of the CLES by tracking post-transplant survival in the EVLP Study Group, compared to a matched contemporaneous Control Group

Potential transplanted lungs that would not be utilized otherwise will be evaluated through normothermic perfusion and ventilation (EVLP) technology. The lungs will then be evaluated by Transplant centers to be given to a recipient on the lung transplant waitlist.

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