Clinical trials: Aortic Valve Stenosis and Insufficiency
Hypertrophic Obstructive Cardiomyopathy
Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT05332691
- Testing
- Transapical beating-heart septal myectomy
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xiang Wei
Aortic Valve Stenosis, Aortic Valve Failure
Portico and Navitor India Clinical Trial
The objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
- Trial name
- NCT05171712
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 6 sites in India
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis, Disorder of Prosthetic Cardiac Valve
Biomarkers in Aortic Stenosis - B.A.S.S.
This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart…
- Conditions
- Aortic Stenosis, Disorder of Prosthetic Cardiac Valve, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- BASS (NCT01334801)
- Testing
- Blood Draw
- Where
- United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Radiographic Contrast Agent Nephropathy, Aortic Valve Stenosis With Insufficiency
The Effect of the Forced Diuresis With Matched Hydration in Reducing Acute Kidney Injury During TAVI
Evaluating whether forced diuresis with matched hydration will reduce the risk of contrast induced nephropathy in patients undergoing Transcatheter Aortic Valve Implantation (TAVI).
- Trial name
- REDUCE-AKI (NCT01866800)
- Testing
- Renal Guard, Conventional Treatment
- Where
- Israel
- Volunteers
- 136 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Heart Valve Diseases, Aortic Valve Stenosis
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions.
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- NCT07068633
- Where
- 2 sites in South Korea
- Volunteers
- 30,000 people
- Sponsor
- Yonsei University
Severe Aortic Stenosis, Aortic Regurgitation
Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or…
- Trial name
- TAVI (NCT03788590)
- Testing
- Jenscare TAVI
- Volunteers
- 133 people
- Sponsor
- Ningbo Jenscare Biotechnology Co., Ltd.
Aortic Valve Stenosis, Aortic Valve Regurgitation
Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis
Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk.
- Trial name
- MATCH-BALL (NCT04548726)
- Testing
- Sapien 3 Transcather Aortic Valve Implant, Myval Transcather Aortic Valve Implant
- Where
- 6 sites in Italy, Spain
- Volunteers
- 416 people
- Sponsor
- Ignacio J. Amat Santos
AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency, Aortic Valve Regurgitation, Aortic Valve Replacement
- Trial name
- EMBLOK II (NCT07129421)
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS")
- Volunteers
- 560 people
- Sponsor
- Emblok, Inc.
Heart Valve Diseases, Aortic Valve Stenosis
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique…
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Regurgitation, Aortic
- Trial name
- CORONATE (NCT05714293)
- Testing
- CT scan with contrast medium
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Stenoses, Aortic Valve, Aortic Insufficiency
Perceval Aortic Bioprostheses : Durability Study.
Aortic valve replacement is one of the most commonly performed procedures in adult cardiac surgery in France. Patients over the age of 65 most often receive a bioprosthetic aortic valve during an isolated aortic valve replacement…
- Conditions
- Stenoses, Aortic Valve, Aortic Insufficiency, Aortic Diseases
- Trial name
- NCT07116265
- Volunteers
- 192 people
- Sponsor
- University Hospital, Montpellier
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Disease, Aortic Valve Stenosis
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the initial clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT06518681
- Testing
- PoliaValve (Aortic)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Ischemic Heart Disease, Aortic Stenosis, Severe
Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass.
- Conditions
- Ischemic Heart Disease, Aortic Stenosis, Severe, Aortic Insufficiency, Mitral Stenosis
- Trial name
- NCT06377449
- Testing
- Ultrasound examination of the lungs
- Where
- Russia
- Volunteers
- 186 people
- Sponsor
- Saint Petersburg State University, Russia
Stenosis, Regurgitation, Aortic
Dokimos Plus Aortic Valve Implant in 80 Patients Diagnosed With a Heart Valve Disease and Requiring Valve Replacement
This study intends to reinforce the current clinical information regarding safety and efficacy of the Dokimos Plus aortic valve prosthesis in patients in whom an aortic valve replacement with a bioprosthesis has been indicated.
- Trial name
- NCT04370041
- Testing
- Dokimos Plus aortic valve
- Where
- 3 sites in Spain
- Volunteers
- 80 people
- Sponsor
- Swan Medical S. L.
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
Transcatheter Aortic Valve Replacement, Hemodynamic Monitoring
Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard therapy for elderly patients with high surgical risks.
- Conditions
- Transcatheter Aortic Valve Replacement, Hemodynamic Monitoring, Aortic Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- APPOSE (NCT04281771)
- Testing
- cardiac MRI
- Where
- Netherlands
- Volunteers
- 92 people
- Sponsor
- Radboud University Medical Center
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
Aortic Valve Stenosis, Aortic Valve Regurgitation
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure
- Trial name
- ECHOCATH (NCT05459233)
- Testing
- Doppler-echocardiography, Invasive hemodynamic measurements
- Where
- 7 sites in United States, Canada
- Volunteers
- 310 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Aortic Stenosis
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
- Trial name
- PROGRESS (NCT02987894)
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 23 sites in Canada, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Symetis SA
Valve Disease, Aortic, Mitral Regurgitation (MR)
DELINEATE-Prospective
Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart.
- Conditions
- Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease
- Trial name
- DELINEATE (NCT07197736)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University