Clinical trials: Stenoses, Aortic
Aortic Stenosis, Cardiomyopathy, Hypertrophic
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
- Trial name
- PII NR3/ViV (NCT03225001)
- Testing
- Edwards SAPIEN XT transcatheter valve, Model 9300TFX
- Where
- 47 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Mitral Regurgitation
Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve…
- Trial name
- ALERT (NCT06099665)
- Testing
- Automated alert
- Where
- 6 sites in United States
- Volunteers
- 2,118 people
- Sponsor
- Tempus AI
Patients With an Indication for an Echocardiographic Examination With Suspicion of Valcular Heart Disease
Point-of-Care Echocardiography in Patients With Known or Suspected Aortic Stenosis
This is a prospective clinical trial intended to capture echocardiographic images in patients clinically indicated for an echocardiographic examination using an additional Point of Care Ultrasound device .
- Trial name
- POC (NCT06717373)
- Testing
- AutoAS
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Caption Health, Inc.
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Prevalence and Characteristics of Transthyretin Amyloidosis in Patients With Left Ventricular Hypertrophy of Unknown Etiology
The main purpose of this study is to determine the prevalence of ATTR Cardiomyopathy among patients admitted due to Left Ventricular Hypertrophy (LVH) >15mm of unknown etiology by using a 99mTc-tracer scintigraphy based protocol
- Trial name
- TTRACK (NCT03842163)
- Testing
- Diagnosis of TTR amyloidosis cardiomyopathy
- Where
- 18 sites in Australia, Austria and 8 more
- Volunteers
- 812 people
- Sponsor
- Pfizer
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the effectiveness and safety of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed difficult for surgical operation.
- Trial name
- NCT01437098
- Testing
- MDT-2111 CoreValve for TAVI
- Where
- 4 sites in Japan
- Volunteers
- 55 people
- Sponsor
- Medtronic Cardiovascular
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Obstructive Hypertrophic Cardiomyopathy
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)
This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic…
- Trial name
- DISCOVER-HCM (NCT05489705)
- Testing
- Mavacamten, Non-mavacamten symptomatic oHCM therapy
- Where
- 101 sites in United States, Austria and 7 more
- Volunteers
- 1,700 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Stenosis
VitaFlowTM II Transcatheter Aortic Valve System Study
A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II - Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic…
- Trial name
- NCT03575039
- Testing
- VitaFlow II Transcatheter Aortic Valve System
- Volunteers
- 178 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Severe Aortic Stenosis
Safety and Performance Study of the Optimum Transcatheter Aortic Valve
The TAVI (Thubrikar Aortic Valve, Inc.) -1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant
- Trial name
- NCT04076150
- Testing
- Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System
- Where
- Poland
- Volunteers
- 5 people
- Sponsor
- Thubrikar Aortic Valve, Inc.
Cardiomyopathy, Hypertrophic
A Study to Evaluate Mavacamten Impact on Myocardial Structure in Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the mavacamten impact on myocardial structure with cardiac magnetic resonance imaging (CMR) in adult participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) [New York…
- Trial name
- MEMENTO (NCT06112743)
- Testing
- Mavacamten
- Where
- 23 sites in United States, Argentina and 4 more
- Volunteers
- 63 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Disease, Aortic Valve Stenosis
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
- Trial name
- VITAL (NCT05977257)
- Testing
- VitaFlow® Transcatheter Aortic Valve Replacement System
- Where
- 4 sites in China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Valve Stenosis
REPRISE EDGE 29 mm EU Study
The objective of the REPRISE EDGE 29 mm EU study is to evaluate performance and safety of the 29 mm LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native…
- Trial name
- NCT02964962
- Testing
- 29 mm LOTUS Edge™ Valve System
- Sponsor
- Boston Scientific Corporation
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
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® SAFESYNC Bioprosthetic Heart Valve, implanted via a…
- Conditions
- Aortic Stenosis Senile, Aortic Stenosis Symptomatic, Aortic Stenosis
- Trial name
- SAFESYNC NG (NCT07806409)
- Testing
- INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
- Volunteers
- 40 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
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, Intracranial Embolism and Thrombosis
NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device
The purpose of this clinical study is to assess the safety, performance, and treatment effect of the use of the AorticLab FLOWer System, in preventing cerebral thromboembolic complications in patients with indication for a TAVI…
- Trial name
- NAUTILUS (NCT04704258)
- Testing
- TAVI (Transcatheter Aortic Valve Implant), FLOWer Embolic Protection System
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 100 people
- Sponsor
- AorticLab Srl
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Heart Failure, Cardiomyopathy, Hypertrophic
A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk
This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.
- Conditions
- Heart Failure, Cardiomyopathy, Hypertrophic, Left Ventricular Hypertrophy
- Trial name
- NCT05646056
- Testing
- Software
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Prolaio
Aortic Valve Stenosis, Valvular Heart Disease
CoreValve Advance-II Study: Prospective International Post-market Study
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
- Trial name
- Advance-II (NCT01624870)
- Where
- 9 sites in Belgium, Czechia and 4 more
- Volunteers
- 200 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure