Clinical trials: Valve Replacement
Aortic Valve Stenosis
Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan
The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of patients after a computed tomography (CT) scan.
- Trial name
- NCT01843426
- Testing
- Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical University of South Carolina
Tricuspid Regurgitation
TTVR STRONG Under Coverage With Evidence Development (CED) Study
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the…
- Trial name
- STRONG (NCT06833476)
- Testing
- EVOQUE
- Where
- United States
- Volunteers
- 2,044 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR).
- Trial name
- CCQ (NCT01852552)
- Testing
- transcatheter aortic valve implantation, Aortic Valve Replacement
- Where
- Italy
- Volunteers
- 518 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Mitral Regurgitation
Tendyne European Experience Registry
TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.
- Trial name
- TENDER (NCT04898335)
- Testing
- Tendyne Mitral Valve System
- Where
- 30 sites in Austria, Belgium and 8 more
- Volunteers
- 400 people
- Sponsor
- LMU Klinikum
Mitral Valve Regurgitation
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device.
- Trial name
- NCT04775108
- Testing
- Epygon™ Transcatheter Mitral Valve System
- Where
- 10 sites in Austria, Italy and 2 more
- Volunteers
- 40 people
- Sponsor
- Epygon
Heart Valve Diseases, Health Behavior
Study of Health Behavior in Patients After Heart Valve Replacement： Longitudinal Studies
To investigates the influencing factors and the pathways of health behavior in patients after heart valve replacement.
- Conditions
- Heart Valve Diseases, Health Behavior, Postoperative Period
- Trial name
- NCT06490952
- Where
- China
- Volunteers
- 219 people
- Sponsor
- Fujian Medical University Union Hospital
Aortic Valve Disease
Quantification of Debris Captured Using TCEP During VIV TAVR With BVF
The objective of this study is to quantify the amount of debris captured by the SENTINEL transcatheter cerebral embolic protection (TCEP) device in patients undergoing valve in valve transcatheter aortic valve replacement (VIV…
- Trial name
- NCT05093764
- Testing
- VIV TAVR with BVF using TCEP
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Saint Luke's Health System
Tricuspid Valve Regurgitation, Tricuspid Valve Disease
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases
- Trial name
- TRIVITA (NCT07516444)
- Testing
- Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
- Where
- United States
- Volunteers
- 730 people
- Sponsor
- VDyne, Inc.
Congenital Heart Disease
Autus Valve Continued Access Study (CAS)
Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT07466745
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Supra-Annular vs. Annular ValvEs for Small Annuli
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
- Trial name
- SAVE (NCT04372381)
- Testing
- Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Where
- 3 sites in United States
- Sponsor
- University of Arizona
Inflammation
Efficacy and Safety of Bovine Intestinal Alkaline Phosphatase (bIAP) During Heart Surgery
This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical…
- Trial name
- APPIRED-II (NCT01144611)
- Testing
- bIAP bolus and 8h infusion
- Where
- Netherlands
- Volunteers
- 53 people
- Sponsor
- Alloksys Life Sciences B.V.
Aortic Stenosis
General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement
Transcarotid transcatheter aortic valve replacement (Transcarotid TAVR) has been increasingly used as an alternative to the transfemoral approach.
- Trial name
- GALATTAVI (NCT06870734)
- Volunteers
- 44 people
- Sponsor
- University Hospital, Caen
Aortic Stenosis
Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry
The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR).
- Trial name
- SAINT-TAVR Ca (NCT06722066)
- Testing
- Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Eunpyeong St. Mary's Hospital
Heart Valve Diseases, Heart; Complications, Valve, Prosthesis
Prevention of Renal Failure by Nitric Oxide in Prolonged Cardiopulmonary Bypass.
Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity.
- Conditions
- Heart Valve Diseases, Heart; Complications, Valve, Prosthesis, Cardiac Valve Replacement Complication
- Trial name
- NCT01802619
- Testing
- inhaled nitric oxide, inhaled Nitrogen
- Where
- China
- Volunteers
- 217 people
- Sponsor
- Xijing Hospital
Tricuspid Regurgitation
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery.
- Trial name
- NCT05436028
- Testing
- Transcatheter Tricuspid Valve Intervention
- Where
- France
- Volunteers
- 161 people
- Sponsor
- Jenscare Scientific
Aortic Stenosis
Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis
The purpose of this study is to evaluate the effectiveness of impedance cardiography (ICG), the HYPERGRAPH test, in detecting left ventricular decompensation in patients with aortic stenosis, compared to cardiac magnetic…
- Trial name
- NCT07230964
- Testing
- Impedance Cardiography Upright/Supine Test
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Dermed Diagnostics, Inc.
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 Stenosis
Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis
To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for…
- Trial name
- NCT02628899
- Testing
- Transfemoral TAVR, SAVR
- Where
- 11 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medstar Health Research Institute
Aortic Valve Stenosis, Aortic Stenosis
Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve
Aortic stenosis is a commonly found heart disease, which often leads to mortality and morbidity. Valve replacement using mechanical prosthetic valve will have an expensive cost especially in the Integrated Heart Center of Cipto…
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Valve Stenoses, Aortic, Aortic Valve Calcification
- Trial name
- NCT04056832
- Testing
- Single Strip Pericardium, Mechanical Prosthetic Valve
- Where
- Indonesia
- Volunteers
- 62 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Mitral Regurgitation
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in…
- Trial name
- APOLLO-EU (NCT05496998)
- Testing
- Medtronic Intrepid™ TMVR TF System
- Where
- 37 sites in Denmark, France and 6 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiovascular