Clinical trials: Severe Heart Valve Disease
Aortic Valve Stenosis, Malignancy
Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis
As for today, transcatheter aortic valve implantation (TAVI) is indicated only in symptomatic patients with severe aortic stenosis (AS) at high surgical risk.
- Trial name
- TOP-AS (NCT03181997)
- Testing
- Native aortic valve, Transcatheter aortic valve implantation (TAVI)
- Where
- Israel
- Volunteers
- 168 people
- Sponsor
- Rabin Medical Center
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
Severe Tricuspid Regurgitation
TRICUS STUDY Euro - Safety and Efficacy of the TricValve® Device
The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk…
- Trial name
- NCT04141137
- Testing
- TricValve® System
- Where
- 10 sites in Austria, Spain
- Volunteers
- 35 people
- Sponsor
- P+F Products + Features GmbH
Heart Valve Diseases, Moderate to Severe Valve Disease in the Elderly
China Elderly Valve Disease Study III (China-DVD3 Study)
This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart…
- Trial name
- NCT07816146
- Where
- China
- Volunteers
- 6,612 people
- Sponsor
- Yongjian Wu, MD, PhD
Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation
A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR
Electrocardiogram (ECG)-based algorithms have been proposed to guide post-TAVI conduction management; however, their ability to predict clinically relevant delayed conduction disturbances remains limited.
- Conditions
- Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation, Right Bundle-Branch Block, Left Bundle-Branch Block
- Trial name
- LATETAVI (NCT07414485)
- Testing
- retrospective health data collection
- Where
- France
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
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.
Amyloidosis Cardiac, Aortic Stenosis, Severe
Analysis of Calcium Score of Severe Aortic Stenosis in Patients With and Without Cardiac Amyloidosis (CAUSATIVE Study)
The concomitant presence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS) may challenge the estimation of stenosis degree.
- Trial name
- CAUSATIVE (NCT06066632)
- Where
- Italy
- Volunteers
- 480 people
- Sponsor
- University Hospital of Ferrara
Severe Aortic Stenosis
CLEAR-AS: CT-FFR-Guided Revascularization in Patients With Severe Aortic Stenosis
Severe aortic stenosis (AS) is often accompanied by coronary artery disease (CAD). While coronary computed tomography angiography (CCTA) is routinely used before aortic valve replacement (AVR) to evaluate coronary anatomy, it…
- Trial name
- CLEAR-AS (NCT07469371)
- Testing
- CCTA plus CT-FFR-informed preoperative decision strategy, CCTA-guided preoperative decision strategy
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
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 Stenosis
Promoting Shared Decision Making for Severe Aortic Stenosis
The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are: Do patient decision aids and clinician skills training course…
- Trial name
- IMPACT SDM (NCT06171737)
- Testing
- Decision Aid, Shared Decision Making Skills Training
- Where
- 8 sites in United States
- Volunteers
- 1,300 people
- Sponsor
- Massachusetts General Hospital
Aortic Stenosis
Vivio AS (Aortic Stenosis) Algorithm Optimization Study
Optimize a candidate software algorithm using data collected with the Vivio system for use as an aid in the identification of heart sounds associated with severe aortic stenosis
- Trial name
- NCT04068402
- Testing
- Vivio System
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ventric Health, LLC
Severe Aortic Valve Stenosis, Aortic Valve Stenosis
Single Antiplatelet Treatment With Ticagrelor or Aspirin After Transcatheter Aortic Valve Implantation
The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully…
- Conditions
- Severe Aortic Valve Stenosis, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Aortic Valve Implantation (TAVI)
- Trial name
- REAC-TAVI2 (NCT05283356)
- Testing
- Ticagrelor 60mg
- Where
- Spain
- Volunteers
- 1,206 people
- Sponsor
- Fundacin Biomedica Galicia Sur
Aortic Valve Stenosis
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality
Randomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or…
- Trial name
- DEDICATE (NCT03112980)
- Testing
- Transcatheter aortic valve implantation, Surgical aortic valve replacement
- Where
- 43 sites in Germany
- Volunteers
- 1,414 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Aortic Regurgitation
Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)
To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical…
- Trial name
- NCT06101888
- Testing
- TaurusTrio™ Heart Valve System
- Where
- 19 sites in China
- Volunteers
- 116 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Aortic Valve Stenosis, Coronary Artery Disease
Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis
Aortic valve stenosis (AS) affects 2-7% of persons > 65 years, symptoms include: angina and dyspnea, dizziness and syncope. Coincidence of coronary artery disease (CAD), also presenting with angina and dyspnea, in patients with…
- Trial name
- TAVI PET (NCT04882488)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
Aortic Regurgitation
Diastolic Dysfunction in Aortic Regurgitation
Follow-up study in patients with severe aortic regurgitation after successful valve replacement. Systolic and diastolic function were assessed and persistent diastolic dysfunction was observed late (7-10 years) after operation.
- Trial name
- NCT00976625
- Testing
- Aortic Valve Replacement
- Where
- Switzerland
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Bern
Tricuspid Regurgitation (TR)
LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd.
- Trial name
- NCT07705594
- Testing
- Transvenous Tricuspid Valve System implantation + OMT, OMT
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Jenscare Scientific
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF)
Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is often performed under rapid right ventricular pacing (burst >180 bpm) with the induction of a functional cardiac arrest for up to…
- Trial name
- EASE-IT-TF (NCT02760771)
- Testing
- with BAV, without BAV
- Where
- Germany
- Volunteers
- 196 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Mitral Regurgitation
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in…
- Trial name
- APOLLO-EU (NCT05496998)
- Testing
- Medtronic Intrepid™ TMVR TF System
- Where
- 37 sites in Denmark, France and 6 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiovascular