Clinical trials: Valvular Insufficiency
Tricuspid Regurgitation, Tricuspid Valve Disease
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
- Trial name
- VISTA-US (NCT05848284)
- Testing
- VDyne Transcatheter Tricuspid Valve Replacement System
- Where
- 11 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- VDyne, Inc.
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
Atrial Fibrillation
Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction
The objective of the study is to evaluate the effectiveness and safety of the reduced dose rivaroxaban (15 mg once daily) as compared to warfarin in non-valvular atrial fibrillation (NVAF) patients with renal dysfunction in…
- Trial name
- CALLIPER (NCT03359876)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Warfarin sodium
- Where
- United States
- Volunteers
- 16,000 people
- Sponsor
- Bayer
Mitral Regurgitation, Tricuspid Regurgitation
Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study
ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation.
- Conditions
- Mitral Regurgitation, Tricuspid Regurgitation, Valvular Heart Disease
- Trial name
- ARB-PMCF (NCT04761120)
- Testing
- Abbott SJM Rigid Saddle Ring, Abbott SJM Séguin Ring, Abbott SJM Tailor Ring
- Where
- 17 sites in United States, Estonia and 5 more
- Volunteers
- 550 people
- Sponsor
- Abbott Medical Devices
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
Coronary Artery Disease, Congestive Heart Failure
Prognostic Indicators as Provided by the EPIC ClearView
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known…
- Conditions
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease, Atrial Fibrillation
- Trial name
- GBMC (NCT01476995)
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Epic Research & Diagnostics, Inc.
Non-valvular Atrial Fibrillation
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients…
- Trial name
- NCT01857622
- Testing
- DU-176b 15mg, DU-176b 30mg, DU-176b 60mg
- Where
- Japan
- Volunteers
- 93 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT05902897
- Testing
- Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis.
- Where
- 3 sites in Brazil
- Volunteers
- 913 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Heart Valve Diseases
Methods Study to Evaluate Use of Cardiac Ultrasound to Assess Heart Valve Abnormality in People.
Methods study to evaluate use of cardiac ultrasound to assess heart valve abnormality in people.
- Trial name
- NCT00359489
- Testing
- cardiac echosonography
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Acromegaly
A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide
The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide
- Trial name
- NCT00234520
- Where
- 33 sites in Belgium, Czechia and 8 more
- Volunteers
- 225 people
- Sponsor
- Ipsen
Mitral Regurgitation, Mitral Valve Disease
AHEAD: European Feasibility Study of the Cardiovalve Transfemoral Mitral Valve System
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation.
- Trial name
- AHEAD (NCT03339115)
- Testing
- Cardiovalve Transfemoral Mitral Valve
- Where
- 11 sites in Germany, Greece and 1 more
- Volunteers
- 30 people
- Sponsor
- Cardiovalve Ltd.
Heart Failure, Cardiomyopathies
Multimodal Physiologic State Intelligence Study
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state…
- Conditions
- Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute
- Trial name
- OMNIPHYS (NCT07814118)
- Testing
- OMNIPHYS Multimodal Ultrasound Imaging System
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
Tricuspid Regurgitation, Tricuspid Valve Disease
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
- Trial name
- VISTA (NCT05797519)
- Testing
- VDyne Transcatheter Tricuspid Valve Replacement System
- Where
- 21 sites in Australia, Austria and 9 more
- Volunteers
- 120 people
- Sponsor
- VDyne, Inc.
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR Pivotal Trial
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- ALIGN-AR (NCT04415047)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 30 sites in United States
- Volunteers
- 180 people
- Sponsor
- JenaValve Technology, Inc.
Mitral Valve Regurgitation, Left Ventricular Dysfunction
VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study
The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or…
- Conditions
- Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure, Mitral Insufficiency
- Trial name
- VIVID (NCT00512005)
- Testing
- Percutaneous mitral valve repair
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Myocor