Clinical trials: Aortic-Stenosis
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
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic…
- Trial name
- PORTICO-IDE (NCT02000115)
- Testing
- Portico transcatheter aortic valve, Commercially available transcatheter aortic valve
- Where
- 70 sites in United States, Australia
- Volunteers
- 1,242 people
- Sponsor
- Abbott Medical Devices
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
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 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
Hypertrophic Cardiomyopathy
A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada
This real-world study will describe the demographic and clinical characteristics and mavacamten treatment of adult patients with obstructive hypertrophic cardiomyopathy who participated in the Bristol-Myers Squibb (BMS)-sponsored…
- Trial name
- NCT06549608
- Testing
- Mavacamten
- Where
- Canada
- Volunteers
- 683 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Stenosis, Severe Aortic Stenosis
A Prospective, Multi-centre, Single Arm, Pivotal Clinical Study to Determine the Safety and Effectiveness of Crea Aortic Valve for Use as a Replacement Aortic Heart Valve
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native…
- Trial name
- CREATE (NCT07734025)
- Testing
- Investigational Transcatheter Aortic Valve Replacement System
- Volunteers
- 30 people
- Sponsor
- Onecrea Medical Inc.
Symptomatic Obstructive Hypertrophic Cardiomyopathy, Healthy Subjects
A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects
The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in healthy subjects. 2. Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses. 3.
- Trial name
- NCT03767855
- Testing
- CK-3773274 - Granules in Capsule, CK-3773274 - Tablets
- Where
- United States
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Cytokinetics
Aortic Stenosis, Symptomatic Aortic Stenosis
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- DurAVR™ EFS (NCT05712161)
- Testing
- DurAVRTM THV System
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Symptomatic Hypertrophic Cardiomyopathy (HCM)
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
- Trial name
- FOREST-HCM (NCT04848506)
- Testing
- Aficamten (5 - 20 mg)
- Where
- 141 sites in United States, Argentina and 17 more
- Volunteers
- 900 people
- Sponsor
- Cytokinetics
Aortic Stenosis
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the…
- Trial name
- SAVI TF (NCT02306226)
- Volunteers
- 1,000 people
- Sponsor
- Symetis SA
Moderate Aortic Valve Stenosis
Aortic Valve Replacement for Moderate Aortic Stenosis With Left Ventricular Decompensation Early Feasibility Study
Obtain safety and effectiveness data to support expansion for aortic valve replacement to include patients with moderate aortic stenosis and left ventricular decompensation.
- Trial name
- NCT07060183
- Testing
- Ross procedure
- Sponsor
- Dermed Diagnostics, Inc.
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical
Aortic Valve Stenosis
DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI
A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.
- Trial name
- TAVI (NCT02070731)
- Testing
- TriGuard HDH
- Where
- 14 sites in France, Germany and 4 more
- Volunteers
- 86 people
- Sponsor
- Keystone Heart
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Breastfeeding, Hypertrophic Cardiomyopathy
Mavacamten Pregnancy Surveillance Program
The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.
- Conditions
- Breastfeeding, Hypertrophic Cardiomyopathy, Pregnancy Related
- Trial name
- NCT05939700
- Testing
- Mavacamten
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Bristol-Myers Squibb
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been…
- Trial name
- NCT07827105
- Testing
- AK-AVS
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- AccurKardia, Inc.
Aortic Valve Stenosis, Aortic Valve Calcification
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- REPRISE I (NCT01383720)
- Testing
- Lotus Valve System
- Where
- 3 sites in Australia
- Volunteers
- 11 people
- Sponsor
- Boston Scientific Corporation