Clinical trials: Surgery (Cardiac)
Coronary Artery Bypass Grafting, Mitral Valve Surgery
Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass
A study to evaluate levosimendan compared with placebo in reducing the composite event rate of all-cause death, perioperative MI, need for new dialysis, or use of mechanical assist (IABP, LVAD or ECMO) in subjects with reduced…
- Conditions
- Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome
- Trial name
- LEVO-CTS (NCT02025621)
- Testing
- Levosimendan
- Where
- 60 sites in United States, Canada
- Volunteers
- 882 people
- Sponsor
- Tenax Therapeutics, Inc.
Congestive Heart Failure
Feasibility Study of BMAC Enhanced CABG
Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium
- Trial name
- NCT01074099
- Testing
- BMAC, CABG only
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Harvest Technologies
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Left Atrial Appendage Exclusion
AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.
- Trial name
- EXCLUDE (NCT00779857)
- Testing
- AtriCure LAA Exclusion System
- Where
- 7 sites in United States
- Volunteers
- 70 people
- Sponsor
- AtriCure, Inc.
Longstanding Persistent Atrial Fibrillation
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial…
- Trial name
- CRYO-AF (NCT01558635)
- Testing
- Cardioblate CryoFlex Surgical Ablation, Mitral Valve surgery, Medtronic Reveal XT Insertable Cardiac Monitor
- Where
- 4 sites in Germany, Israel and 2 more
- Volunteers
- 17 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial…
- Trial name
- ABLATE-PAS (NCT01694563)
- Testing
- Synergy Ablation System
- Where
- 49 sites in United States
- Volunteers
- 365 people
- Sponsor
- AtriCure, Inc.
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.
Atrial Fibrillation
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
- Trial name
- ABLATE (NCT00560885)
- Testing
- AtriCure Bipolar System
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- AtriCure, Inc.
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Bleeding Cardiac Surgery Patients
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
- Trial name
- FARES-2 (NCT05523297)
- Testing
- Octaplex, Frozen Plasma Product, Human
- Where
- 13 sites in United States, Canada
- Volunteers
- 420 people
- Sponsor
- Octapharma
Coronary Artery Bypass, Myocardial Infarction
The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED)
The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG surgery.
- Conditions
- Coronary Artery Bypass, Myocardial Infarction, Ventricular Dysfunction, Left, Stroke
- Trial name
- RED-CABG (NCT00872001)
- Testing
- Acadesine, Normal Saline
- Volunteers
- 3,080 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypertension
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well…
- Trial name
- SPRINT (NCT00799604)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- The Medicines Company
Myocardial Ischemia, Acute Coronary Syndrome
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention…
- Trial name
- NCT00089895
- Testing
- Eptifibatide (Integrilin)
- Volunteers
- 9,406 people
- Sponsor
- Organon and Co
Aortic Stenosis, Cardiomyopathy, Hypertrophic
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
- Trial name
- PII NR3/ViV (NCT03225001)
- Testing
- Edwards SAPIEN XT transcatheter valve, Model 9300TFX
- Where
- 47 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system.
- Trial name
- NCT01051518
- Testing
- Medtronic CoreValve System
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Acute Kidney Injury
Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery.
- Trial name
- AKITA (NCT05126303)
- Testing
- RMC-035
- Where
- 29 sites in United States, Canada and 3 more
- Volunteers
- 177 people
- Sponsor
- Guard Therapeutics AB
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet