Clinical trials: Aortic Valve Stenosis
Aortic Valve Stenosis
POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the…
- Trial name
- POLESTAR (NCT03910751)
- Testing
- Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
- Where
- 15 sites in Belgium, Canada and 2 more
- Volunteers
- 252 people
- Sponsor
- Erasmus Medical Center
Aortic Valve Stenosis
Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man
- Trial name
- NCT03779620
- Testing
- Ultrasound treatment of Calcified aortic valve
- Where
- 2 sites in France, Netherlands
- Volunteers
- 30 people
- Sponsor
- Cardiawave SA
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Aortic Valve Stenosis
Valvuloplasty Scoring Balloon Catheter First-in-Man Study
The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of…
- Trial name
- NCT01514994
- Testing
- AngioScore's Valvuloplasty Scoring Balloon
- Where
- Canada
- Volunteers
- 25 people
- Sponsor
- Spectranetics Corporation
Hypertrophic Obstructive Cardiomyopathy
Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy
Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.
- Trial name
- PRIZMA-pilot (NCT04470102)
- Testing
- mitral valve repair by edge-to-edge technique, Septal myectomy
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Aortic Stenosis, Transcatheter Aortic Valve Implantation
Reversibility of Cardiac Conduction Disturbances Following TAVI
The management of patients with conduction disturbances (CDs) after transcatheter aortic valve implantation (TAVI) is unclear, especially in those with de novo electrocardiographic CDs (ECG-CDs) such as left bundle branch block.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Conduction Disturbances
- Trial name
- TAVI-REVERSE (NCT06481137)
- Testing
- Electrophysiological study (EP study), ePatch (extended Holter Monitoring)
- Where
- Spain
- Volunteers
- 209 people
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
Aortic Valve Stenosis, Regurgitation, Aortic
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe…
- Conditions
- Aortic Valve Stenosis, Regurgitation, Aortic, Prosthesis Failure
- Trial name
- NCT03520101
- Testing
- TAVI_ViV procedure with Edwards valve, TAVI_ViV procedure with CoreValve system
- Where
- Canada
- Volunteers
- 102 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Aortic Regurgitation, Mitral Regurgitation
Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease
This project aims to validate sex-specific biologic signatures associated with aortic valve disease developed in a large multicenter CMR registry, using unsupervised phenomapping.
- Conditions
- Aortic Regurgitation, Mitral Regurgitation, Aortic Stenosis
- Trial name
- NCT06780241
- Testing
- CMR, Quality of Life Questionnaire
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- The Cleveland Clinic
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
HCM - Hypertrophic Cardiomyopathy
Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind, Placebo-Controlled Trial Using 68Ga/18F-FAPI PET/CMR
his is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of Henagliflozin (an SGLT2 inhibitor) on myocardial fibrosis burden in patients with non-obstructive hypertrophic…
- Trial name
- NCT07294495
- Testing
- Henagliflozin (SGLT2 Inhibitor)
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai East Hospital
Hypertrophic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy
Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve
The aim of this study is to assess microvascular function as determined by a cardiovascular magnetic resonance measurement of whole-heart (global) perfusion reserve.
- Conditions
- Hypertrophic Cardiomyopathy, Non-ischemic Dilated Cardiomyopathy, Microvascular Ischaemia of Myocardium
- Trial name
- NCT03249272
- Testing
- Regadenoson, Adenosine
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Duke University
Aortic Valve Stenosis
RESPOND Post Market Study
The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available…
- Trial name
- RESPOND (NCT02031302)
- Testing
- Lotus Valve System
- Where
- 41 sites in Colombia, Finland and 11 more
- Volunteers
- 1,064 people
- Sponsor
- Boston Scientific Corporation
Obstructive Hypertrophic Cardiomyopathy, Mavacamten
Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM).
- Conditions
- Obstructive Hypertrophic Cardiomyopathy, Mavacamten, Radiofrequency Ablation
- Trial name
- NCT06856265
- Testing
- radiofrequency ablation, Mavacamten
- Volunteers
- 40 people
- Sponsor
- Shanghai Chest Hospital
Cardiomyopathy, Hypertrophic
A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to characterize the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MYK-224 in participants with obstructive Hypertrophic Cardiomyopathy (oHCM)
- Trial name
- MERCUTIO (NCT05556343)
- Testing
- MYK-224
- Where
- 25 sites in United States, Italy and 2 more
- Volunteers
- 18 people
- Sponsor
- Bristol-Myers Squibb
Hypertrophic Obstructive Cardiomyopathy, Stereotactic Body Radiotherapy
Safety and Efficacy of Stereotactic Body Radiotherapy in the Treatment of Hypertrophic Obstructive Cardiomyopathy
This study is designed to rigorously evaluate the safety and effectiveness of Stereotactic Body Radiotherapy (SBRT) as an innovative, non-invasive treatment for Hypertrophic Obstructive Cardiomyopathy (HOCM).
- Trial name
- SAFECARE (NCT06167876)
- Testing
- Stereotactic Body Radiotherapy (SBRT) Treatment
- Where
- 4 sites in China
- Volunteers
- 36 people
- Sponsor
- Second Xiangya Hospital of Central South University
Aortic Stenosis
A Clinical Trial of the Transcatheter Aortic Valve Implantation System With a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients With Severe Aortic Stenosis
A Clinical Trial of the Transcatheter Aortic Valve Implantation System with a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients with Severe Aortic Stenosis
- Trial name
- NCT05673525
- Testing
- Transcatheter Aortic Valve Implantation (KOKA-VALVE)
- Where
- China
- Volunteers
- 131 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Aortic Valve Stenosis, Mitral Regurgitation
Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions
Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.
- Conditions
- Aortic Valve Stenosis, Mitral Regurgitation, Coronary Artery Disease, Fractional Flow Reserve
- Trial name
- POTUS (NCT05374733)
- Testing
- Coronary Physiology assessment
- Where
- Netherlands
- Volunteers
- 150 people
- Sponsor
- Erasmus Medical Center
Aortic Valve Stenosis
Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation
Aortic valve stenosis (AS) is the most common valve disease among older individuals. In symptomatic AS, mortality is high, and the only treatment that improves prognosis and survival is transcatheter aortic valve implantation…
- Trial name
- TAVI (NCT06283940)
- Testing
- Physiotherapist-led exercise based cardiac rehabilitation (PT-X)
- Where
- Sweden
- Volunteers
- 135 people
- Sponsor
- Vastra Gotaland Region
Aortic Valve Stenosis
Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
The management of symptomatic patients with moderate Aortic Stenosis (AS) remains challenging and tests that would give more definitive answers are needed.
- Trial name
- NCT02792452
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- London North West Healthcare NHS Trust
Aortic Valve Stenosis
Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.
The aim of this collaborative analysis is to evaluate stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve.
- Trial name
- CENTER (NCT03588247)
- Testing
- transcatheter aortic valve implantation
- Where
- Netherlands
- Volunteers
- 12,000 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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