Clinical trials: Stenoses, Aortic
Hypertrophic Cardiomyopathy (HCM), Obstructive HCM (oHCM)
Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy
The goal of this clinical trial is designed to characterise the safety, tolerability, efficacy, and PK of Aom0304 across oHCM and nHCM populations and to inform dose selection for future Phase 3 development.
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Obstructive HCM (oHCM), Non-obstructive HCM (nHCM)
- Trial name
- NCT07675668
- Testing
- QG101-23-0 enteric coated capsule (60/120/240/360 mg BID), QG101-23-0 enteric coated capsule (120/240/360/480mg BID)
- Volunteers
- 56 people
- Sponsor
- Amckaus PTY LTD.
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten Outcomes in Hypertrophic Cardiomyopathy (HCM) and the Associated Patient and Physician Experiences in the US
The purpose of this study is to understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy (HCM) treated with mavacamten, and to understand patient and physician…
- Trial name
- SPARC-HCM (NCT07557498)
- Testing
- Mavacamten
- Where
- United Kingdom
- Volunteers
- 362 people
- Sponsor
- Bristol-Myers Squibb
Aortic Stenosis, Aortic Regurgitation
Mitroflow DL Post Approval Study- North America
Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
- Conditions
- Aortic Stenosis, Aortic Regurgitation, Aortic Valve Insufficiency, Heart Valve Diseases
- Trial name
- NCT02351726
- Testing
- Mitroflow DL
- Where
- 13 sites in United States
- Volunteers
- 186 people
- Sponsor
- LivaNova
Aortic Stenosis
PARTNER II Trial: S3iCAP
Following completion of enrollment in the PARTNER II SAPIEN 3 intermediate risk trial, this trial provided continued access to treatment for subjects with severe aortic stenosis who were at intermediate surgical risk.
- Trial name
- PII S3i CAP (NCT02687035)
- Testing
- SAPIEN S3 valve
- Where
- 56 sites in United States, Canada
- Volunteers
- 1,822 people
- Sponsor
- Edwards Lifesciences
Cardiomyopathy, Hypertrophic
A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
- Trial name
- ODYSSEY-HCM (NCT05582395)
- Testing
- Mavacamten
- Where
- 224 sites in United States, Australia and 21 more
- Volunteers
- 580 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Stenosis
Venus-Vitae Pivotal Study Smart-Align Study
The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
- Trial name
- NCT05991271
- Testing
- Venus-Vitae Transcatheter Heart Valve System
- Volunteers
- 150 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Severe Aortic Valve Stenosis
The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.
- Trial name
- BSC07 (NCT05847751)
- Testing
- Aortic valve replacement
- Where
- 7 sites in Egypt, Lebanon and 1 more
- Volunteers
- 51 people
- Sponsor
- Ceric Sàrl
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
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to <12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein…
- Trial name
- ORION-20 (NCT06597019)
- Testing
- Inclisiran
- Where
- 66 sites in United States, Argentina and 21 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- REPRISE III (NCT02202434)
- Testing
- Lotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve System
- Where
- 58 sites in United States, Australia and 4 more
- Volunteers
- 1,425 people
- Sponsor
- Boston Scientific Corporation
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
Hypertrophic Cardiomyopathy
Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM).
- Trial name
- PIONEER-OLE (NCT03496168)
- Testing
- mavacamten
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Stenosis
PremiCron Suture for Cardiac Valve Repair
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
- Trial name
- PremiValve (NCT04096859)
- Where
- 2 sites in Germany, Spain
- Volunteers
- 198 people
- Sponsor
- Aesculap AG
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV EU-EFS
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical…
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure
- Trial name
- NCT06510855
- Testing
- DurAVR™ THV System
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
Aortic Valve Replacement With Trifecta(TM)
To confirm the clinical safety and effectiveness of the Trifecta valve.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00475709
- Testing
- Trifecta Aortic Heart Valve
- Where
- 18 sites in United States
- Volunteers
- 1,022 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
A Study to Evaluate the Neuro-embolic Consequences of TAVR
A prospective, multi-center study to evaluate the neuro-embolic consequences of Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- NCT02073864
- Where
- 5 sites in United States
- Volunteers
- 46 people
- Sponsor
- Keystone Heart
Aortic Valve Stenosis
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories.
- Trial name
- PREVAIL-20J (NCT01419015)
- Testing
- SAPIEN XT NovaFlex delivery system
- Where
- 4 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Hypertrophic Cardiomyopathy
Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects.
- Trial name
- NCT02329184
- Testing
- MYK-461
- Where
- 7 sites in United States
- Volunteers
- 15 people
- Sponsor
- MyoKardia, Inc.