Clinical trials: Valvular Heart Disease Patients
Hypertrophic Cardiomyopathy
3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is very common. The thickened heart muscle can disrupt the normal functioning of the heart's electrical system, resulting in fast or irregular heartbeats.
- Trial name
- 3D-CMH (NCT03550573)
- Testing
- CardioInsight™ Noninvasive 3D Mapping System
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Atrial Fibrillation, Stroke
CHAMPION-AF Clinical Trial
The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial…
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- CHAMPION-AF (NCT04394546)
- Testing
- WATCHMAN FLX LAAC Device, Non-Vitamin K Oral Anticoagulant
- Where
- 141 sites in United States, Australia and 14 more
- Volunteers
- 3,000 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis, Symptomatic Aortic Stenosis
Structured Shared Decision Making for Patients Undergoing SAVR or TAVR
Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk.
- Trial name
- TOGETHER (NCT05711186)
- Testing
- Structured SDM, Usual Care
- Where
- 2 sites in Switzerland
- Volunteers
- 140 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Coronary Artery Disease, Aortic Stenosis, Severe
NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation
The aim of the IMPACTavi prospective cohort study is to test feasibility and safety of clinically indicated intravascular coronary imaging with NIRS-IVUS in addition to routine coronary angiography in patients scheduled for TAVI…
- Trial name
- IMPACTavi (NCT04976062)
- Testing
- Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 150 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Atrial Fibrillation
Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the…
- Trial name
- EXPLORE-Xa (NCT00742859)
- Testing
- betrixaban, Warfarin
- Where
- 21 sites in United States, Canada
- Volunteers
- 508 people
- Sponsor
- Portola Pharmaceuticals
Atrial Fibrillation, Left Ventricular Failure
Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry
To evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having: atrial fibrillation severe impaired leftventricular…
- Conditions
- Atrial Fibrillation, Left Ventricular Failure, Left Ventricular Impaired Function, Aortic Valve Stenosis
- Trial name
- NCT02444104
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Atrial Fibrillation, Intracardiac Thrombus
Response of Intracardiac Thrombus to Anticoagulants in Patients With Non-valvular Atrial Fibrillation (LYSIS)
This study aims to analyze changes in the immune status, metabolic status, and host microbiome community structure in non-valvular atrial fibrillation patients with intracardiac thrombus.
- Trial name
- LYSIS (NCT06141538)
- Testing
- Observational; No Interventions were given.
- Where
- China
- Volunteers
- 500 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Aortic Valve Stenosis
Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan
The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of patients after a computed tomography (CT) scan.
- Trial name
- NCT01843426
- Testing
- Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical University of South Carolina
Tricuspid Regurgitation
TTVR STRONG Under Coverage With Evidence Development (CED) Study
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the…
- Trial name
- STRONG (NCT06833476)
- Testing
- EVOQUE
- Where
- United States
- Volunteers
- 2,044 people
- Sponsor
- Edwards Lifesciences
Atrial Fibrillation
Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation
The investigators' central hypothesis is that in patients with atrial fibrillation, anticoagulation with Apixaban reduces the rate of decline in cognitive function, when compared to Warfarin.
- Trial name
- ARISTA (NCT03839355)
- Testing
- Apixaban, Warfarin
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Mayo Clinic
Heart Valve Diseases, Health Behavior
Study of Health Behavior in Patients After Heart Valve Replacement： Longitudinal Studies
To investigates the influencing factors and the pathways of health behavior in patients after heart valve replacement.
- Conditions
- Heart Valve Diseases, Health Behavior, Postoperative Period
- Trial name
- NCT06490952
- Where
- China
- Volunteers
- 219 people
- Sponsor
- Fujian Medical University Union Hospital
Atrial Fibrillation
Atrial Fibrillation Patient Preference Study
The main research question of this patient survey is to assess AF patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (VKA or NOACs and, in case of…
- Trial name
- PRiSMA-AF (NCT02611635)
- Testing
- VKA: Warfarin (Waran), NOAC: Rivaroxaban (Xarelto, BAY59-7939), NOAC: Dabigatran etexilate
- Where
- Sweden
- Volunteers
- 382 people
- Sponsor
- Bayer
Acute Kidney Injury, Heart Valve Diseases
Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury
Identification of risk factors of acute kidney injury (AKI). It is hypothesized that there might be a correlation between brain oximetry, tissue saturation of thenar muscle and marker of AKI in blood - neutrophil…
- Trial name
- NCT02979275
- Testing
- Open heart surgery on cardiopulmonary bypass.
- Where
- Poland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Medical University of Gdansk
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.
Atrial Fibrillation, Left Atrial Appendage Occlusion
Left Atrial Appendage Occlusion in Patients With Non-valvular Atrial Fibrillation From Shanghai
The prognostic implication of left atrial appendage occlusion (LAAO) procedure in non-valvular atrial fibrillation (NVAF) patients from China is still unclear.
- Trial name
- LAAO-SH (NCT03987945)
- Testing
- left atrial appendage occlusion devices
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai 10th People's Hospital
Tricuspid Valve Regurgitation, Tricuspid Valve Disease
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
- Conditions
- Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases
- Trial name
- TRIVITA (NCT07516444)
- Testing
- Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System, Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
- Where
- United States
- Volunteers
- 730 people
- Sponsor
- VDyne, Inc.
Aortic Valve Stenosis
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking.
- Trial name
- REVALVE (NCT06557798)
- Testing
- Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication, Surgical explantation and aortic valve replacement, Conservative management
- Where
- 63 sites in Denmark, Finland and 9 more
- Volunteers
- 550 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Heart Valve Disease
CopenHeartVR - Integrated Rehabilitation of Patients After Heart Valve Surgery
The aim of the study is to investigate the effect of an integrated rehabilitation programme, consisting of physical exercise training and psycho-educational consultations, for patients after heart valve surgery.
- Trial name
- CopenHeartVR (NCT01558765)
- Testing
- Integrated rehabilitation
- Where
- Denmark
- Volunteers
- 147 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Tricuspid Regurgitation
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery.
- Trial name
- NCT05436028
- Testing
- Transcatheter Tricuspid Valve Intervention
- Where
- France
- Volunteers
- 161 people
- Sponsor
- Jenscare Scientific
Heart Failure, Valvulopathy
Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)
This trial is a single-center, open-label, randomized study designed to assess the impact of a rapid up-titration of Guideline-Directed Medical Therapy (GDMT) on heart failure with reduced ejection fraction (HFrEF) patients…
- Conditions
- Heart Failure, Valvulopathy, Aortic Stenosis, Aortic Regurgitation Disease
- Trial name
- OPTIMAV (NCT06667128)
- Testing
- Rapid Uptitration of Guideline-Directed Medical Therapy, Elecsys® NT-proBNP - Roche Diagnostics, Rapid Up-Titration GDMT Group with Hospital Monitoring
- Where
- Italy
- Volunteers
- 160 people
- Sponsor
- IRCCS Ospedale San Raffaele