Clinical trials: Valvulopathy, open to volunteers
Tricuspid Valve Regurgitation, Heart Valve Disease
The TRICURE EU Pivotal Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases
- Trial name
- TRICURE EU (NCT06581471)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 8 sites in Belgium, Germany
- Volunteers
- 80 people
- Sponsor
- TRiCares
Mitral Regurgitation
Cephea Early Feasibility Study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral…
- Trial name
- NCT05061004
- Testing
- Cephea Mitral Valve System
- Where
- 22 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Aortic Valve Regurgitation
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure
- Trial name
- ECHOCATH (NCT05459233)
- Testing
- Doppler-echocardiography, Invasive hemodynamic measurements
- Where
- 7 sites in United States, Canada
- Volunteers
- 310 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Mitral Regurgitation
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
- Trial name
- EMBRACE (NCT07409285)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- HighLife SAS
Tricuspid Regurgitation Functional
Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation
The purpose of this clinical trial is as follows. To assess the safety of the investigational medical device "Pivot Bridge" in participants aged 18 years or older with massive or greater functinal tricuspid regurgitation (TR) who…
- Trial name
- Pivot TR (NCT07385625)
- Testing
- Pivot Bridge
- Where
- 4 sites in South Korea
- Volunteers
- 20 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Severe Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI).
All patients with severe aortic stenosis undergoing evaluation for TAVI are routinely subjected to a series of assessments: Pre-implantation: thoraco-abdominal CT angiography, coronary angiography, echocardiography, clinical…
- Trial name
- ROARING-TAVI (NCT06679517)
- Testing
- TAVI
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- University Hospital of Ferrara
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
The purpose of the ACHILLES-HF trial (ACHIeving optimaL medicaL therapy through pErcutaneous treatment of Secondary mitral regurgitation to improve outcome in Patients with Heart Failure with reduced ejection fraction) is to test…
- Trial name
- ACHILLES-HF (NCT07758023)
- Testing
- M-TEER, Standardized GDMT Up-Titration
- Volunteers
- 520 people
- Sponsor
- University Medical Center Mainz
Heart Valve Disease, TAVI
Enhanced Valves Interventions and Safe AI Generated End Results
This non-interventional study aims to use artificial intelligence to improve the prediction of transcatheter heart valve interventions and optimize patient outcomes.
- Conditions
- Heart Valve Disease, TAVI, M-TEER, TTVI
- Trial name
- ENVISAGE (NCT07213531)
- Testing
- Medical imaging analysis via artificial intelligence algorithms
- Where
- 15 sites in United States, Canada and 3 more
- Volunteers
- 21,000 people
- Sponsor
- Montreal Heart Institute
Aortic Valve Insufficiency, Aortic Valve Stenosis
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Trial name
- NCT05172973
- Testing
- SAPIEN X4/X4S THV
- Where
- 37 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Valvular Heart Disease
Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement
This study aims to understand why there may be differences between the measurements of the aortic valve taken before and during surgery.
- Trial name
- SAVR-CT-AVA (NCT07125469)
- Testing
- The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses
- Where
- Italy
- Volunteers
- 82 people
- Sponsor
- Maria Cecilia Hospital
Mitral Regurgitation
Enhanced External Counter Pulsation on Afterload Mismatch Rate in Post-TEER (PAMPER)
The goal of this multicenter, randomized, double-blind controlled study is to learn about the individuals after transcatheter edge-to-edge mitral valve repair (TEER).
- Trial name
- NCT06227286
- Testing
- EECP
- Where
- 6 sites in China
- Volunteers
- 176 people
- Sponsor
- Sun Yat-sen University
AORTIC VALVE DISEASES, Thromboembolism
Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
- Trial name
- RENOVATE (NCT04258488)
- Testing
- Rivaroxaban Oral Tablet, Vitamin K antagonist(warfarin)
- Where
- 16 sites in South Korea
- Volunteers
- 1,300 people
- Sponsor
- Joon Bum Kim
Aortic Stenosis
Deep Learning Enhanced Detection of Aortic Stenosis - The DETECT-AS-Diagnostic Study
The DETECT-AS Diagnostic Study will assess the performance of artificial intelligence (AI) risk predictions to detect aortic stenosis using results from portable electrocardiogram (ECG) and cardiac ultrasound devices.
- Trial name
- NCT06749145
- Testing
- Portable 1-lead electrocardiogram, Point-of-care ultrasound, AI-ECG risk algorithm
- Where
- 3 sites in United States
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Yale University
Severe Aortic Valve Stenosis, Cardiovascular Diseases
Pilot Study to Evaluate a Noninvasive Electrocardiographic Monitoring Strategy Associated With Early Discharge in Patients With Conduction Disorders Following TAVI Implantation (IMPROVE Study)
Study to evaluate the efficacy and safety of a non-invasive electrocardiographic monitoring strategy associated with early discharge in patients with conduction disorder after transfemoral TAVI implantation, and its potential…
- Trial name
- IMPROVE (NCT07456280)
- Testing
- Standard care, PhysioMem PM 100 4G ambulatory monitoring system
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Heart Valve Disease, Mitral Valve (MV) Regurgitation
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging…
- Conditions
- Heart Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis
- Trial name
- VALVE-COMPASS (NCT07267117)
- Where
- 15 sites in China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
The study will describe how mavacamten is used in routine care for Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), including use as monotherapy or with other background/concomitant oHCM medications.
- Trial name
- REMAP-HCM (NCT07846059)
- Testing
- Mavacamten
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Bristol-Myers Squibb
Aortic Valve Stenosis
The Leipzig TAVI Registry
A single-center registry including all patients treated with TAVI at the Heart Center, Leipzig, Germany
- Trial name
- NCT05015452
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- Germany
- Volunteers
- 20,000 people
- Sponsor
- Helios Health Institute GmbH
Heart Valve Diseases
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality
- Trial name
- NCT04442100
- Testing
- valve prosthetics
- Where
- Russia
- Volunteers
- 500 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Bicuspid Aortic Valve (BAV)
A Study of Chinese Congenital Bicuspid Aortic Valve
Pervious studies indicated that the prevalence of bicuspid aortic valve（BAV） might be higher in China. There is a familial predisposition to the development of BAV.
- Trial name
- NCT06802016
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Ruijin Hospital