Clinical trials: Aortic-Stenosis
Aortic Diseases
INFLATE Study: Investigation of the Safety and Performance of a Novel PTV Balloon in Patients Undergoing TAVI for Severe Aortic Stenosis
This clinical investigation is being done to evaluate the safety and effectiveness of a new device, a PTV Balloon, that will be used to open up an area in the heart (the valve) before and potentially after placing a new valve in…
- Trial name
- NCT06816485
- Testing
- PTV (Percutaneous Transcatheter Valvuloplasty) Balloon
- Where
- 9 sites in Spain
- Volunteers
- 93 people
- Sponsor
- Biosensors Europe SA
Aortic Valve Disease, Aortic Valve Insufficiency
J-Valve Compassionate Use
J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA
- Conditions
- Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- NCT03876964
- Testing
- Transcatheter Aortic Valve Replacement
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Carotid Stenosis
Gadobutrol Enhanced MRA of the Supra-aortic Vessels
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days.
- Trial name
- GEMSAV (NCT01344447)
- Testing
- Gadobutrol (Gadovist, BAY86-4875)
- Where
- 56 sites in United States, Argentina and 12 more
- Volunteers
- 479 people
- Sponsor
- Bayer
Hypertrophic Cardiomyopathy
A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases.
- Trial name
- NCT06181617
- Testing
- Quality of life assessment
- Where
- Japan
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Symptomatic Severe Aortic Stenosis
Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
- Trial name
- START YOUNG (NCT06861361)
- Testing
- Myval balloon-expandable THV Series, Surgical bioprosthetic valve
- Where
- 49 sites in Austria, Estonia and 12 more
- Volunteers
- 1,180 people
- Sponsor
- Ceric Sàrl
Severe Aortic Stenosis
Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
This study is a prospective, non-randomized, observational, post-market follow-up trial designed to evaluate the safety and efficacy of the RENATUS® Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT07414342
- Testing
- RENATUS® TAVR
- Where
- 4 sites in China
- Volunteers
- 800 people
- Sponsor
- Beijing Balance Medical Technology Co., Ltd
Cardiomyopathy
Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)
The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) receiving cibenzoline in Japan
- Trial name
- NCT07541833
- Testing
- Mavacamten
- Where
- Japan
- Volunteers
- 36 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Stenosis, Aortic Valve Insufficiency
Clinical Investigation for the Foldax Tria Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the Foldax Tria Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- NCT06192706
- Testing
- Foldax Tria Aortic Valve
- Where
- 10 sites in India
- Volunteers
- 50 people
- Sponsor
- Foldax, Inc
Cardiomyopathy, Hypertrophic
A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
- Trial name
- NCT06253221
- Testing
- Mavacamten
- Where
- 47 sites in United States, Australia and 7 more
- Volunteers
- 44 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Disorder, Aortic Valve Insufficiency
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
- Conditions
- Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure
- Trial name
- NCT01651052
- Testing
- Heart Valve Surgery
- Where
- 2 sites in Poland
- Volunteers
- 133 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Calcific, Aortic Valve Stenosis
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.
- Trial name
- PROGRESS (NCT04889872)
- Testing
- SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,250 people
- Sponsor
- Edwards Lifesciences
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII A (NCT01314313)
- Testing
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Where
- 57 sites in United States, Canada
- Volunteers
- 2,032 people
- Sponsor
- Edwards Lifesciences
Cardiomegaly
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy
The purpose of the study is to determine whether the ability of MEK162 to antagonize MEK activation in NS HCM patients, who usually have upstream mutations in the Ras-Raf-Mek-Erk pathway that lead to MEK activation, would be…
- Trial name
- NCT01556568
- Testing
- MEK162
- Where
- 2 sites in United States, United Kingdom
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE neo2™ Post Market Clinical Follow up Study
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT04655248
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Where
- 19 sites in Denmark, Germany and 6 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan
The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in patients with obstructive hypertrophic cardiomyopathy (HCM) receiving mavacamten in Japan
- Trial name
- NCT07383025
- Testing
- Mavacamten
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- Bristol-Myers Squibb
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
- Trial name
- MAPLE-HCM (NCT05767346)
- Testing
- Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg), Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)
- Where
- 71 sites in United States, Brazil and 11 more
- Volunteers
- 175 people
- Sponsor
- Cytokinetics
Aortic Valve Stenosis
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra Aortic valve in real-world patients.
- Trial name
- NCT02434263
- Testing
- Hydra TAVI
- Where
- 6 sites in Greece, Hong Kong and 4 more
- Volunteers
- 165 people
- Sponsor
- Vascular Innovations Co. Ltd.
Aortic Stenosis, Symptomatic Aortic Stenosis
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are…
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03314857
- Testing
- SAPIEN XT THV with the NovaFlex+ delivery system
- Where
- 3 sites in China
- Volunteers
- 67 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (oHCM) and as multiple doses in adults with…
- Trial name
- NCT06347159
- Testing
- EDG-7500
- Where
- 21 sites in United States
- Volunteers
- 79 people
- Sponsor
- Edgewise Therapeutics, Inc.
Aortic Valve Stenosis
The Medtronic TAVR 2.0 US Clinical Study
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk…
- Trial name
- NCT02738853
- Testing
- Medtronic Transcatheter Aortic Valve 2.0 Replacement System
- Where
- 8 sites in United States
- Volunteers
- 93 people
- Sponsor
- Medtronic Cardiovascular