For more information about cardiac surgery clinical trials at Dartmouth-Hitchcock Heart & Vascular Center, please email HVCresearch@hitchcock.org
CTSN MSC for COVID-19 ARDS
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MESENCHYMAL STROMAL CELLS FOR THE TREATMENT OF MODERATE TO SEVERE COVID-19 ACUTE RESPIRATORY DISTRESS SYNDROM
The primary objective of this study is to evaluate the efficacy and safety of MSC remestemcel-L plus standard of care compared to placebo plus standard of care in patients with ARDS due to COVID-19.
PI: Alexander Iribarne, MD Status: Currently Recruiting |
CTSN PACeS
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ANTICOAGULATION FOR NEW-ONSET POST-OPERATIVE ATRIAL FIBRILLATION AFTER CABG
The primary 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 new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.
PI: Alexander Iribarne, MD Status: Currently Recruiting |
ALLERGAN
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Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA)
Allergan has developed a botulinum toxin type A nerotoxin complex, AGN-151607, for the prevention of post-operative atrial fibrillation (POAF) in patient undergoing cardica surgery, AGN-151607 will be injected intraperatively into discrete targets of the heart, namely the epicaridal fat pads near the pulmonary veins and atria. The administration of AGN-151607 is intended to neromodulate the ganglionic plexi in these regions, thus lowering the risk of developing POAF.
PI: Alexander Iribarne, MD Status: Currently Recruiting ClinicalTrials.gov Identifier: NCT03779841 |
QUARK
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QPI-1002 PHASE 3 FOR PREVENTION OF MAKE IN SUBJECTS AT HIGH RISK FOR AKI FOLLOWING CARDIAC SURGERY
This is a randomized, double-blind, placebo-controlled, Phase 3 trial to evaluate a 10 mg/kg dose of QPI-1002 versus placebo for the prevention of MAKE in subjects who are at high risk for AKI following cardiac surgery. Subjects with high risk are defined as having one or more of the following risk factors: a history of diabetes requiring insulin use, albuminuria (urine albumin/creatinine > 30 mcg/mg), renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2). Subjects will be stratified by region, number of the above three risk factors present, and age (18 to <45 years and ≥45 years).
PI: Alexander Iribarne, MD Status: Active Follow-Up ClinicalTrials.gov Identifier: NCT03510897 |
CARILLON
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ASSESSMENT OF THE CARILLON MITRAL CONTOUR SYSTEM IN TREATING FUNCTIONAL MITRAL REGURGITATION ASSOCIATED WITH HEART FAILURE
The objective of this clinical trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation associated with HF.
PI: Alexander Iribarne, MD Status: Active Follow Up ClinicalTrials.gov Identifier: NCT03142152 |
VEST
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A MULTI-CENTER, RANDOMIZED, WITHIN-SUBJECT-CONTROLLED, OPEN LABEL STUDY OF THE SAFETY AND EFFECTIVENESS OF VEST, VENOUS EXTERNAL SUPPORT
In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. To determine safety of the VEST and to demonstrate the effectiveness of the VEST in limiting intimal hyperplasia by providing permanent support to saphenous vein grafts.
PI: Alexander Iribarne, MD Status: Active Follow Up ClinicalTrials.gov Identifier: NCT03209609 |
CTSN-TR
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EVALUATING THE BENEFIT OF CONCURRENT TRICUSPID VALVE REPAIR DURING MITRAL SURGERY
Evaluate the efficacy and safety of performing tricuspid valve (TV) repair in patients with either moderate tricuspid regurgitation (TR) or less than moderate TR with tricuspid annular dilation undergoing mitral valve surgery (MVS).
PI: Jock McCullough, MD Status: Active Follow Up ClinicalTrials.gov Identifier: NCT02675244 |