Clinical trials: Cardiac Valve Surgery
Mitral Annular Calcification
Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at…
- Trial name
- SITRAL (NCT02830204)
- Testing
- Mitral Valve Replacement (MVR) with Sapien3
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Baylor Research Institute
Postoperative Atelectasis
GO2 PEEP Study: Bidirectional Oxygenation Valve in Postoperative Atelectasis
This study compares a novel breathing device, called the GO2 Mouthpiece, to the standard breathing tool called the incentive spirometer, thus improving respiratory dynamics of the postoperative patient.
- Trial name
- NCT04253834
- Testing
- Incentive spirometer, GO2 Mouthpiece
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Emory University
Mitral Valve Insufficiency
The Use of Paravertebral Block for Cardiac Surgery
Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy.
- Trial name
- NCT02180893
- Testing
- Paravertebral Block
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- NYU Langone Health
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Cardiac Disease, Mitochondrial Biogenesis
CO as a Stimulant for Mitochondrial Biogenesis in Human Cardiac Muscle
This study will test if inhalation of Carbon Monoxide (CO) will increase the numbers of mitochondria in heart muscle. Mitochondria are the small components of muscle and other cells that convert fuel and oxygen to the easily…
- Conditions
- Cardiac Disease, Mitochondrial Biogenesis, Carbon Monoxide
- Trial name
- NCT01727167
- Testing
- 200ppm CO for one hour, Control
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- John J Freiberger
Cardiomyopathy, Cardiovascular Diseases
Improving Mitral Repair for Functional Mitral Regurgitation
The investigators are interested in determining the best surgical technique to correct functional mitral regurgitation, as there is currently not one technique that is established to work better than the other.
- Conditions
- Cardiomyopathy, Cardiovascular Diseases, Congestive Heart Failure, Coronary Artery Disease
- Trial name
- IMPROVE-FMR (NCT03366649)
- Testing
- Undersizing Mitral Annuloplasty, Papillary Muscle Approximation
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Emory University
Aortic Valve Stenosis With Insufficiency, Aortic Valve Stenosis
Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
- Trial name
- TRITON (NCT01445171)
- Testing
- Aortic Valve Replacement with EDWARDS INTUITY Valve System
- Where
- 6 sites in Austria, Germany
- Volunteers
- 295 people
- Sponsor
- Edwards Lifesciences
Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery.
- Conditions
- Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return, Truncus Arteriosus, Pulmonary Atresia With Ventricular Septal Defect
- Trial name
- T-NOX (NCT04452188)
- Testing
- Normoxia (with controlled re-oxygenation), Standard of care ventilation
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Michigan
Mitral Valve Insufficiency, Coronary Artery Disease
Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation
Coronary artery bypass grafting (CABG) is a procedure that people with coronary artery disease (CAD) may undergo to increase blood flow to the heart.
- Trial name
- NCT00806988
- Testing
- Mitral Valve Repair, CABG
- Where
- 27 sites in United States, Canada and 1 more
- Volunteers
- 301 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Elite Valve System
The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a…
- Trial name
- MISSION (NCT02907463)
- Where
- 23 sites in Austria, Denmark and 7 more
- Volunteers
- 280 people
- Sponsor
- Edwards Lifesciences
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation
AVJ-514 Japan Trial
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart…
- Conditions
- Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence
- Trial name
- NCT02520310
- Testing
- AVJ-514
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Bypass Grafting, Heart Valve Surgery
VItamin D Metabolism in SEnescent Cardiac Surgery Patients
Advanced age is associated with an increase in postoperative morbidity and mortality in cardiac surgery patients. In detail, compared with younger patients those aged 75 years and older have significantly higher rates of…
- Trial name
- VISE (NCT01378221)
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Blood Loss, Surgical
Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the…
- Trial name
- NCT00448864
- Testing
- Ecallantide
- Where
- 15 sites in United States
- Volunteers
- 75 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Coronary Artery Disease, Valvular Heart Disease
Sugammadex Titration in Cardiac Surgery Patients
Sugammadex is frequently used to reverse the effects of neuromuscular blocking drugs. The recommended doses are 2 mg/kg or 4 mg/kg depending upon the depth of neuromuscular blockade.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease, Aorta Disease, Heart Failure
- Trial name
- NCT05246397
- Testing
- Sugammadex administration
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Washington
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- TRANSFORM™ (NCT01700439)
- Testing
- EDWARDS INTUITY valve
- Where
- 29 sites in United States
- Volunteers
- 934 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease
Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
The study is being done to determine if the Endovent pulmonary catheter kit, used for port access surgery, can be used as a passageway for a pacing wire.
- Trial name
- NCT01631188
- Testing
- Minimally Invasive Aortic Valve, Minimally Invasive Aortic Valve Surgery, Manipulation in OR surgical technique
- Volunteers
- 100 people
- Sponsor
- Rutgers, The State University of New Jersey
Aortic Valve Disorder
Frequency of Reduced Leaflet Motion After Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement.
This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the…
- Trial name
- NCT02696226
- Testing
- SAVR Warfarin, SAVR Aspirin, TAVR Warfarin and clopidogrel
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- The Cleveland Clinic
Aortic Stenosis
Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement
The use of MRI have shown that the incidence of postoperative cerebral lesions due to cerebral embolization is high (1). Nonetheless the extent of postoperative neurological dysfunction is only a fraction of the actual amount of…
- Trial name
- NCT01319799
- Testing
- Open heart surgery
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Sahlgrenska University Hospital
Cardiovascular Disease
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral replacement and mitral valve plasty are the effective methods to the mitral valve disease.
- Trial name
- ANOLAF (NCT03347695)
- Testing
- Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients), Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fujian Medical University