Clinical trials: Valve Heart Disease
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
Delirium, Ischemic Stroke
CTSN Embolic Protection Trial
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
- Conditions
- Delirium, Ischemic Stroke, Acute Kidney Injury, Heart Valve Disease
- Trial name
- EMPRO (NCT06027788)
- Testing
- CardioGard Embolic Protection Cannula, Standard Aortic Cannula
- Where
- 24 sites in United States, Canada
- Volunteers
- 842 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Congenital Heart Disease, Tetrology of Fallot
Harmony TPV Post-Approval Study
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT05077774
- Testing
- Harmony TPV System
- Where
- 20 sites in United States, Canada
- Volunteers
- 174 people
- Sponsor
- Medtronic Cardiovascular
Heart Failure, Valve Heart Disease
Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment
Heart Failure and valvular heart disease are disproportionate problems in rural and remote Australia (RRA). Echocardiography is the best imaging investigation, and essential for management, but access to this essential test shows…
- Trial name
- AGILE-Echo (NCT05558605)
- Testing
- AI-guided echo, Standard echo
- Where
- Australia
- Volunteers
- 612 people
- Sponsor
- Baker Heart and Diabetes Institute
Ethics, Cardiac Rehabilitation
The Role of 4 Different Consent Approaches on a Pilot Study to Increase Cardiac Rehabilitation Attendance
Cardiac Rehabilitation is a lifestyle and exercise program for patients with heart disease. Cardiac Rehabilitation is strongly recommended in guidelines, but only 30% of eligible patients attend.
- Conditions
- Ethics, Cardiac Rehabilitation, Coronary Heart Disease (CHD), Heart Failure
- Trial name
- MOST-CR (NCT07123480)
- Testing
- Usual Care Group, More Support and Tools
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Baystate Medical Center
Cardiac Rehabilitation, Heart Failure
Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery
The RECOVER study, titled Cardiac Rehabilitation Cohort at the Medicine Campus Davos for Exploration of Recovery, is a prospective, non-interventional, monocentric cohort study conducted at the Hochgebirgsklinik Davos.
- Conditions
- Cardiac Rehabilitation, Heart Failure, Cardiac Arrest (CA), ACS (Acute Coronary Syndrome)
- Trial name
- RECOVER (NCT07096973)
- Where
- Switzerland
- Volunteers
- 10,000 people
- Sponsor
- Hochgebirgsklinik Davos
Valve Disease, Heart
Medtronic Cardiac Surgery PMCF Registry
This registry is being conducted to support ongoing post-market surveillance activities.
- Trial name
- NCT04073420
- Testing
- Surgical Heart Valve Repair Products, Surgical Heart Valve Replacement Products
- Where
- 26 sites in United States, Austria and 8 more
- Volunteers
- 2,700 people
- Sponsor
- Medtronic Cardiac Surgery
Severe Tricuspid Regurgitation
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
- Trial name
- PATHFINDER (NCT07321899)
- Testing
- Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System, Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
- Where
- 13 sites in United States
- Volunteers
- 1,186 people
- Sponsor
- Medtronic Cardiovascular
Structural Heart Abnormality, Valve Heart Disease
Capitalizing on AI to CapTure Undiagnosed Structural Heart Disease
Doctors are testing a new tool called EchoNext to see if it can help find heart problems earlier. EchoNext looks at the heart's electrical test, called an ECG, and uses artificial intelligence (AI) to check for signs of…
- Conditions
- Structural Heart Abnormality, Valve Heart Disease, Heart Diseases, Cardiovascular Diseases
- Trial name
- CACTUS (NCT07843004)
- Testing
- EHR Alert
- Where
- United States
- Volunteers
- 4,000 people
- Sponsor
- Pierre Elias
Structural Heart Disease, Mitral Valve Regurgitation
The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry
A significant number of patients with severe mitral and tricuspid valve disease have been previously treated with either valve repair with annuloplasty rings or valve replacement with bioprosthetic/mechanical valves.
- Trial name
- AP ViV (NCT07296016)
- Where
- Hong Kong
- Volunteers
- 15 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Tricuspid Regurgitation (TR), Valvular Heart Diseases
Robotic Transjugular Transcatheter Tricuspid Valve Replacement
Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide.
- Conditions
- Tricuspid Regurgitation (TR), Valvular Heart Diseases, Transcatheter Valve Replacement
- Trial name
- Robotic Lux (NCT07516145)
- Testing
- Transcatheter tricuspid valve replacement
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Mitral Annulus Calcification, Rheumatic Heart Disease
Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC).
- Trial name
- SMARTMAC (NCT06952374)
- Testing
- SmartWave Lithotripsy balloon
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
AORTIC VALVE DISEASES, Calcification; Heart
Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
This is a prospective study that aims to develop clinical calculators that will report on the underlying rate of aortic valve calcification.
- Trial name
- NCT07819344
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
Mitral Valve Regurgitation
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
- Trial name
- APOLLO (NCT03242642)
- Testing
- Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
- Where
- 85 sites in United States, Canada and 1 more
- Volunteers
- 1,056 people
- Sponsor
- Medtronic Cardiovascular
Tricuspid Regurgitation
Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the…
- Trial name
- TRIPLACE (NCT06033274)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 31 sites in United States, Canada and 6 more
- Volunteers
- 800 people
- Sponsor
- Montefiore Medical Center
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
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
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.