Clinical trials: Valvulopathy
Mitral Regurgitation, Mitral Insufficiency
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP).
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases
- Trial name
- SUMMIT (NCT03433274)
- Testing
- Tendyne Mitral Valve System, MitraClip System
- Where
- 78 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Abbott Medical Devices
Mitral Valve Insufficiency, Coronary Artery Disease
Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
People with coronary artery disease (CAD) or people who have had a heart attack may develop a leak in the mitral valve of their heart and may therefore need to undergo surgery to fix the valve.
- Trial name
- NCT00807040
- Testing
- Mitral Valve Repair with Annuloplasty, Mitral Valve Replacement
- Where
- 21 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Symptomatic Aortic Stenosis, Aortic Valve Stenosis
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic…
- Conditions
- Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement
- Trial name
- SMART (NCT04722250)
- Testing
- Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems, Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
- Where
- 92 sites in United States, Canada and 11 more
- Volunteers
- 1,103 people
- Sponsor
- Medtronic Cardiovascular
Congenital Heart Diseases, Aortic Valve Disorder
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients
The investigators hope to learn 1) if the addition of prophylaxis with vancomycin will decrease the rate of cefazolin non-susceptible surgical site infections (SSI), in high risk population 2) to develop better understanding of…
- Trial name
- NCT01619982
- Testing
- Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride, Cefazolin 30 mg/kg body weight
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Stanford University
Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart…
- Conditions
- Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation
- Trial name
- NCT02675244
- Testing
- TV Annuloplasty, MVS
- Where
- 41 sites in United States, Canada and 1 more
- Volunteers
- 401 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Mitral Valve Insufficiency, Heart Failure
Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart…
- Trial name
- REDUCE FMR (NCT02325830)
- Testing
- Carillon Mitral Contour System
- Where
- 31 sites in Australia, Czechia and 6 more
- Volunteers
- 163 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Congenital Heart Disease, Tetrology of Fallot
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of…
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT02979587
- Testing
- Harmony TPV System
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 86 people
- Sponsor
- Medtronic Heart Valves
Heart Valve Disease, Coronary Artery Disease
RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery
Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen.
- Trial name
- RiaCT (NCT01283321)
- Testing
- Human fibrinogen concentrate, apheresis platelets
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Emory University
Mitral Heart Valve Disease
Magna Mitral - 23mm
The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.
- Trial name
- NCT01312779
- Testing
- Implantation of CEP Magna Mitral Model 7000TFX
- Where
- 6 sites in United States, Poland
- Volunteers
- 39 people
- Sponsor
- Edwards Lifesciences
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- TRACER (NCT02768870)
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 4 sites in Italy, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
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
Hyperglycemia, Aortic Valve Replacement
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
The overall research plan is to test the hypothesis that intraoperative treatment of hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial function and short-term outcomes compared with…
- Conditions
- Hyperglycemia, Aortic Valve Replacement, Aortic Stenosis, Cardiac Surgery
- Trial name
- NCT01187329
- Testing
- hyperinsulinemic normoglycemic clamp (HNC), control group
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Cleveland Clinic
Myocardial Infarction, Heart Failure
The Improving ATTENDance to Cardiac Rehabilitation Trial
The benefits of cardiac rehabilitation are well known. However, despite center based cardiac rehabilitation (CBCR) representing guideline-based care for patients with cardiovascular disease, most patients do not complete the…
- Conditions
- Myocardial Infarction, Heart Failure, Heart Valve Diseases, Cardiac Event
- Trial name
- iATTEND (NCT03646760)
- Testing
- HYCR, CBCR
- Where
- United States
- Volunteers
- 282 people
- Sponsor
- Henry Ford Health System
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.
Hypertrophic Cardiomyopathy
Hypertrophic Regression With N-Acetylcysteine in HCM
The purpose of the sudy is to conduct a small study to gather the preliminary data for future lage scale clinical studies that will be designed test the potential beneficial effect of over-the counter study anti-oxidant drug…
- Trial name
- HALT (NCT01537926)
- Testing
- N-acetylcysteine
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- The University of Texas Health Science Center, Houston
Mitral Regurgitation, Mitral Valve Regurgitation
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip…
- Conditions
- Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects, Heart Failure
- Trial name
- COAPT (NCT01626079)
- Testing
- MitraClip System
- Where
- 86 sites in United States, Canada
- Volunteers
- 776 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Valve-in-valve Procedures, Aortic Stenosis
The ShortCut™ Continued Access Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
- Conditions
- Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction
- Trial name
- ShortCut-CAS (NCT06211296)
- Testing
- Shortcut
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pi-cardia
Coronary Artery Disease, Angina Pectoris
An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery
The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Cardiac Valve Disease
- Trial name
- SB (NCT01783483)
- Testing
- SternaLock Blue closure system, Suture Wire
- Where
- 12 sites in United States
- Volunteers
- 236 people
- Sponsor
- Zimmer Biomet