Clinical trials: Valve
Severe Aortic Stenosis
Comparison of a Single Versus Double Perclose Technique for TAVR
Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis.
- Trial name
- Single (NCT06173115)
- Testing
- Perclose Proglide system
- Where
- 25 sites in China
- Volunteers
- 876 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Aortic Stenosis, Severe, Aortic Valve Stenosis
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
The aim of this study is to learn if the Computed Tomography scan (CT scan) and heart echo scan TransThoracic Echo scan (TTE or heart echo scan) taken before a Transcatheter Aortic Valve Implantation (TAVI) procedure can be used…
- Trial name
- CONTINUUM-CT (NCT06596460)
- Testing
- TAVI planning CT (adapted)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Barts & The London NHS Trust
Aortic Valve Disease
Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure…
- Trial name
- INDICATE (NCT07120048)
- Testing
- Edwards INSPIRIS RESILIA Aortic Valve
- Where
- 15 sites in Germany
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease
KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance
KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.
- Trial name
- KONECTION (NCT07619872)
- Testing
- Edwards KONECT RESILIA AVC
- Where
- 3 sites in Germany
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Tricuspid Regurgitation
TTVR Early Feasibility Study
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a…
- Trial name
- NCT04433065
- Testing
- Intrepid™ TTVR System
- Where
- 20 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis, Hypertension,Essential
Blood Pressure Reduction in Patients With Asymptomatic Aortic VALVE Stenosis
The aim of this study is to investigate the effect of strict blood pressure control versus conventional care in patients with asymptomatic moderate to severe aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Hypertension,Essential, Heart Failure
- Trial name
- BP-AVALVE (NCT04613193)
- Testing
- Blood presssure reduction
- Where
- 6 sites in Denmark
- Volunteers
- 60 people
- Sponsor
- Henrik Wiggers
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
Aortic Valve Stenosis
VitaFlow LIBERTY Europe
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the…
- Trial name
- NCT06535659
- Testing
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Where
- 9 sites in Ireland, Italy and 3 more
- Volunteers
- 222 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Moderate Aortic Valve Stenosis
Evolut™ EXPAND TAVR II Pivotal Trial
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
- Trial name
- NCT05149755
- Testing
- Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
- Where
- 94 sites in United States, Australia and 14 more
- Volunteers
- 650 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
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
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
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
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
Mitral Regurgitation
The REValve Clinical Trial an Evaluation Of the ReValve Palmetto Valve for the Replacement of the Native Mitral VaLVE
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
- Trial name
- The REsOLVE Tr (NCT07450911)
- Testing
- ReValve System
- Where
- 3 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- ReValve Solutions Inc.
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
Mitral Valve Prolapse Arrhythmic Risk
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis.
- Trial name
- MVP-Risk (NCT07830888)
- Testing
- Risk prediction model
- Where
- Norway
- Volunteers
- 500 people
- Sponsor
- Oslo University Hospital
Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
This study aims to establish an active surveillance system to evaluate the safety and effectiveness of innovative medical devices used in the interventional treatment of structural heart disease.
- Trial name
- ASSEE-SHD (NCT07848152)
- Where
- 11 sites in China
- Volunteers
- 2,200 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Mitral Regurgitation, Mitral Disease
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
- Trial name
- SAPIEN M3 EFS (NCT03230747)
- Testing
- Edwards SAPIEN M3 System
- Where
- 9 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Edwards Lifesciences
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
Mitral Regurgitation
EFS of the CardioMech MVRS
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
- Trial name
- NCT04820764
- Testing
- CardioMech MVRS
- Where
- 12 sites in United States
- Volunteers
- 35 people
- Sponsor
- CardioMech AS