Clinical trials: Heart Valve Diseases
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
The goal of this clinical trial is to assess if the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTO G2 TVSTR) is safe and efficient in treating severe tricuspid regurgitation in adult patients.
- Trial name
- FIM-TRICSTER (NCT07536724)
- Testing
- TRICENTOG2 Transcatheter Valve System for Tricuspid Regurgitation (TRICENTOG2 TVSTR)
- Where
- 2 sites in Uzbekistan
- Volunteers
- 10 people
- Sponsor
- Medira GmbH
Severe Aortic Valve Stenosis, Valvular Heart Disease
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis.
- Conditions
- Severe Aortic Valve Stenosis, Valvular Heart Disease, Aortic Valve Stenosis
- Trial name
- HYSPANIA (NCT07566624)
- Testing
- Hydra THV
- Where
- 5 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Fundación EPIC
Cardiac Valve Disease, Coronary Heart Disease
Superficial Parasternal Block Combined With Rectus Sheath Block for Open Cardiac Surgery
The investigators will examine whether the combination of a superficial parasternal block and rectus sheath block with multimodal analgesia can enhance postoperative pain control and reduce opioid administration when compared to…
- Trial name
- NCT07890857
- Testing
- Parasternal and rectus sheath block, ropivacaine 0.25 %
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Hôpital du Valais
Coronary Artery Disease, Heart Valve Diseases
Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery
This prospective randomized study evaluates the nephroprotective effects of exogenous nitric oxide delivered to the extracorporeal circulation circuit during cardiac surgery with cardiopulmonary bypass.
- Conditions
- Coronary Artery Disease, Heart Valve Diseases, Cardiomyopathies, Acute Kidney Injury
- Trial name
- NephroNO (NCT03527381)
- Testing
- Nitric Oxide, Standard CPB
- Volunteers
- 96 people
- Sponsor
- Nikolay Kamenshchikov
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
EFS of the DUO System for Tricuspid Regurgitation
The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
- Conditions
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases
- Trial name
- TANDEM II (NCT05913908)
- Testing
- DUO Transcatheter Tricuspid Coaptation Valve System
- Where
- 18 sites in United States, Poland
- Volunteers
- 15 people
- Sponsor
- CroiValve Limited
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
The Swedish CArdioPulmonary bioImage Study (SCAPIS) is a unique, large-scale national research initiative involving 30,000 randomly selected individuals aged 50-64, recruited between 2014 and 2018.
- Conditions
- Coronary Artery Disease, Arterial Stiffness, Blood Pressure, AORTIC VALVE DISEASES, Mitral Valve Stenosis and/or Insufficiency
- Trial name
- SCAPIS-ReEx (NCT07476703)
- Testing
- Coronary computer tomography (CCTA), Echocardiograhy and aortic ultrasound, Liver elastography
- Where
- Sweden
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- Danderyd Hospital
Heart Valve Diseases, Heart Diseases
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
TRIBLAZE is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in a minimum of 75 participants who will receive the Edwards Lifesciences TRIFORMIS RESILIA surgical…
- Conditions
- Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Disease
- Trial name
- TRIBLAZE (NCT07684313)
- Testing
- Edwards TRIFORMIS RESILIA heart valve
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Edwards Lifesciences
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Cardiac Valve Disease, Coronary Artery Disease
Telehealth Interventions for Cardiac Surgery
The goal of this clinical trial is to compare telehealth monitoring at home against usual care in patients undergoing planned heart surgery. The main questions it aims to answer are: 1.
- Conditions
- Cardiac Valve Disease, Coronary Artery Disease, Surgical Complication
- Trial name
- TICS (NCT05621954)
- Testing
- Telehealth Monitoring
- Where
- United Kingdom
- Volunteers
- 318 people
- Sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
Valve Heart Disease
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements are performed using a bioprosthesis.
- Trial name
- BASELINE (NCT04843072)
- Testing
- EVOLUT R/PRO/PRO+/FX bioprosthesis, Edwards Sapien S3/Ultra bioprosthesis, MYVAL/Octacor/Octapro bioprosthesis
- Where
- 14 sites in United States, Austria and 10 more
- Volunteers
- 600 people
- Sponsor
- Erasmus Medical Center
Heart Disease, Aging
Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement.
Background: The prevalence of both senile cardiac amyloidosis (CA) and aortic stenosis (AS) markedly increases with age. Aortic stenosis increases left ventricular pressure overload.
- Conditions
- Heart Disease, Aging, Amyloidosis, Aortic Valve Stenosis
- Trial name
- AMYLOCARTESIAN (NCT02260466)
- Testing
- a basal LV septum biopsy
- Where
- 5 sites in France
- Volunteers
- 186 people
- Sponsor
- French Cardiology Society
Tricuspid Valve Disease, Heart Valve Diseases
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.
- Conditions
- Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
- Trial name
- TRICAV-II (NCT06458907)
- Testing
- TricValve System, Optimal medical therapy
- Where
- 34 sites in United States
- Volunteers
- 780 people
- Sponsor
- P+F Products + Features USA Inc.
Valvular Heart Disease
Evaluation of Valvular Heart Disease Using Cardiac CT
The EVIDENTIA Registry is a multicenter study designed to evaluate valvular heart disease (VHD) using cardiac CT. It aims to assess cardiac valve anatomy, function, and myocardial characteristics through detailed CT analysis. 1.
- Trial name
- NCT06937125
- Where
- Japan
- Volunteers
- 350 people
- Sponsor
- Toho University
Heart Diseases, Heart Failure
Echocardiography in Nursing Home
The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes…
- Conditions
- Heart Diseases, Heart Failure, Heart Valve Diseases
- Trial name
- ECHOGER (NCT06445231)
- Testing
- Implementation of echocardiography in nursing homes
- Where
- France
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- Nantes University Hospital
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
Prospective Evaluation of AI-ECG for SHD Detection
AI-ECG-SHD is a multicentre prospective observational diagnostic accuracy study evaluating artificial intelligence-enhanced electrocardiography (AI-ECG) for the detection of structural heart disease in adults undergoing…
- Conditions
- Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis), Heart Failure With Reduced Ejection Fraction (HFrEF; Diagnosis), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)
- Trial name
- AI-ECG-SHD (NCT07057466)
- Testing
- Traditional 12-lead Electrocardiogram, Apple Watch Series 4 Single-lead Electrocardiogram, Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram
- Where
- 6 sites in United Kingdom
- Volunteers
- 590 people
- Sponsor
- Imperial College London
Congenital Heart Disease, Valvular Heart Disease
Echocardiographic Assessment of Valvular Dysfunction in Children With CHD
This cross-sectional study aims to assess the type and severity of valvular dysfunction by echocardiography in children with congenital heart disease.
- Trial name
- NCT07866924
- Volunteers
- 100 people
- Sponsor
- Assiut University
Heart Valvular Disease
Multi-center Research Clinical Trial Protocol for Etiology-pathology and Repair Classification of Mitral and Tricuspid Valves
The choice of valve repair is very important in the treatment of cardiac valve disease, and its core is the etiology pathology analysis, which directly determines the design of repair strategy and the quality of postoperative…
- Trial name
- NCT07863531
- Testing
- Valve repair, Valve replacement
- Volunteers
- 200 people
- Sponsor
- Keli Huang
Tricuspid Regurgitation, Heart Valve Diseases
The CLASP III TR 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 Repair procedure using the…
- Conditions
- Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT07859709
- Testing
- PASCAL Precision system Treated, Medicare Eligible Untreated Patients
- Where
- United States
- Volunteers
- 2,350 people
- Sponsor
- Edwards Lifesciences
Normal and Abnormal Cardiovascular Physiology
Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging
Background: Magnetic resonance imaging (MRI) is an important non-invasive tool to study and diagnose cardiovascular disease. MRI scanners use strong magnetic fields and radio waves to create pictures of body organs.
- Trial name
- NCT03581318
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Postoperative Delirium, Heart Valve Diseases
Transcranial Doppler and Artificial Intelligence Prediction of Postoperative Delirium in Heart Valve Surgery
Postoperative delirium is a frequent complication after cardiac surgery. This prospective observational study will evaluate whether cerebral blood flow velocity measured by transcranial Doppler before and during elective heart…
- Trial name
- NCT07858578
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Osman Sila Aydin