Clinical trials: Heart Disease, Valvular
Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Trial name
- NCT07278310
- Testing
- TAVR Device, Siegel TAVR Device
- Where
- United States
- Volunteers
- 1,025 people
- Sponsor
- MiRus
Atrial Fibrillation
Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)
In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Thailand proposed this non-interventional study (NIS) to gain insight into the safety…
- Trial name
- NCT03247569
- Testing
- Edoxaban
- Where
- 6 sites in Thailand
- Volunteers
- 300 people
- Sponsor
- Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
Aortic Valve Stenosis, Aortic Valve Insufficiency
Enable® Aortic Sutureless Bioprosthesis Evaluation
The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.
- Trial name
- EASE (NCT01720342)
- Testing
- Aortic Valve Replacement surgery
- Where
- 17 sites in France, Germany and 5 more
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Mitral Valve Regurgitation
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation
KALIOS is indicated for the surgical treatment of mitral regurgitation by mitral valve repair.It is intended for mitral valve repair using conventional open heart or minimally invasive techniques.
- Trial name
- NCT03908983
- Testing
- Kalios Implant
- Where
- 9 sites in Austria, Germany and 2 more
- Volunteers
- 100 people
- Sponsor
- Kephalios
Mitral Valve Insufficiency
Edwards PASCAL Transcatheter Valve Repair System Registry
This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.
- Trial name
- PASCALRegistry (NCT04443218)
- Testing
- Edwards PASCAL Transcatheter Valve Repair System
- Where
- 14 sites in Germany, Switzerland
- Volunteers
- 220 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Hydra Registry - Italy Experience
Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.
- Trial name
- NCT05956652
- Testing
- Hydra Transcatheter Aortic Valve System
- Where
- 4 sites in Italy
- Sponsor
- Sahajanand Medical Technologies Limited
Atrial Fibrillation
Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients
To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).
- Trial name
- NCT02792335
- Testing
- apixaban, dabigatran, rivaroxaban
- Volunteers
- 28,000 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
A Trial of HS-10511 in Healthy Subjects
This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single…
- Trial name
- NCT06210607
- Testing
- HS-10511 Tablets
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Mitral Regurgitation
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029337
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
Tricuspid Valve Regurgitation
MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
- Trial name
- NCT04071652
- Testing
- Mistral implantation
- Where
- 3 sites in Israel
- Volunteers
- 17 people
- Sponsor
- Mitralix
Heart Valve Disease
European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where ESPOIR pulmonary valve (PV) is prescribed in the usual manner in…
- Trial name
- ESPOIR (NCT02035540)
- Testing
- Decellularized human valves
- Where
- 8 sites in Belgium, France and 6 more
- Volunteers
- 121 people
- Sponsor
- corlife
Hypertrophic Cardiomyopathy (HCM)
Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy
This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).
- Trial name
- REDWOOD-HCM (NCT04219826)
- Testing
- CK-3773274 (5 - 15 mg), CK-3773274 (10 - 30 mg)
- Where
- 22 sites in United States, Italy and 2 more
- Volunteers
- 96 people
- Sponsor
- Cytokinetics
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)
The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- NCT02491255
- Testing
- Lotus Valve System
- Where
- 5 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
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.
Mitral Regurgitation
Feasibility Study of the Tioga TMVR System
The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR>=3+)
- Trial name
- NCT06038838
- Testing
- Tioga TMVR System
- Where
- 5 sites in Brazil, Georgia and 2 more
- Volunteers
- 30 people
- Sponsor
- Tioga Cardiovascular, Inc.
Mitral Valve Prolapse
St. Jude Medical Percutaneous Mitral Valve Repair Study
The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
- Trial name
- SJM PMVr (NCT01500148)
- Testing
- PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
- Where
- United Kingdom
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
A Study Using Electronic Health Information to Learn About Rivaroxaban Compared to Warfarin in Participants With Non-valvular Atrial Fibrillation (NVAF) and Diabetes
In people with type 2 diabetes, the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.
- Trial name
- RIVA-DM (NCT04509193)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin
- Where
- United States
- Volunteers
- 116,049 people
- Sponsor
- Bayer
Aortic Valve Stenosis, Cardiovascular Diseases
Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)
The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Ventricular Outflow Obstruction
- Trial name
- GALILEO-4D (NCT02833948)
- Testing
- Acetylsalicylic acid, Clopidogrel, Rivaroxaban
- Where
- 25 sites in United States, Canada and 5 more
- Volunteers
- 231 people
- Sponsor
- ECRI bv
Aortic Valve Disease, Aortic Valve Insufficiency
J-Valve TF Early Feasibility Study
The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to…
- Conditions
- Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Regurgitation
- Trial name
- JVTF EFS (NCT06034028)
- Testing
- J-Valve TF System
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC