Clinical trials: Aortic Valve Disorder
Aortic Valve Stenosis
Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic…
- Trial name
- PORTICO-IDE (NCT02000115)
- Testing
- Portico transcatheter aortic valve, Commercially available transcatheter aortic valve
- Where
- 70 sites in United States, Australia
- Volunteers
- 1,242 people
- Sponsor
- Abbott Medical Devices
Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation
A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR
Electrocardiogram (ECG)-based algorithms have been proposed to guide post-TAVI conduction management; however, their ability to predict clinically relevant delayed conduction disturbances remains limited.
- Conditions
- Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation, Right Bundle-Branch Block, Left Bundle-Branch Block
- Trial name
- LATETAVI (NCT07414485)
- Testing
- retrospective health data collection
- Where
- France
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Ischemic And Bleeding Risk Assessment After TAVR
Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).
- Trial name
- FOCUS ONE (NCT06000943)
- Testing
- Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
- Where
- 12 sites in Belgium, Chile and 3 more
- Volunteers
- 2,500 people
- Sponsor
- Niguarda Hospital
Aortic Stenosis, Non-rheumatic
Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure
To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of…
- Trial name
- HEPAVALV (NCT01823393)
- Testing
- Heparin, NaCl
- Where
- France
- Volunteers
- 94 people
- Sponsor
- University Hospital, Montpellier
Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation)
Cerebral Regional Oxygen Saturation During TAVI - The CROS-TAVI Prospective Registry
This single-center, non-commercial clinical study investigates how different types of transcatheter aortic valve prostheses affect cerebral oxygen saturation during the procedure (TAVI - Transcatheter Aortic Valve Implantation).
- Conditions
- Aortic Stenosis Disease, TAVI(Transcatheter Aortic Valve Implantation), Cerebral Oxygen Saturation, Hemodynamic Changes
- Trial name
- CROS-TAVI (NCT07016789)
- Testing
- Near-infrared spectroscopy monitoring (NIRS) INVOS 5100C
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Hypertrophic Cardiomyopathy (HCM), Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy
This retrospective cohort study aims to evaluate the clinical efficacy and safety of mavacamten in adult patients with obstructive hypertrophic cardiomyopathy (oHCM).
- Trial name
- MAVA-HCM (NCT07529938)
- Testing
- mavacamten
- Where
- China
- Volunteers
- 222 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Aortic Valve Stenosis
Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has rapidly been adopted into clinical practice, but concerns have been raised regarding periprocedural complications like e.g. myocardial injury, stroke or acute kidney injury.
- Trial name
- NCT02080299
- Testing
- Remote ischemic preconditioning (RIPC)
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- University Hospital, Essen
Postoperative Delirium, Postoperative Cognitive Dysfunction
Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement
Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted…
- Conditions
- Postoperative Delirium, Postoperative Cognitive Dysfunction, Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement
- Trial name
- COSTA (NCT04535076)
- Testing
- Transcatheter Aortic Valve Implantation, Surgical Aortic Valve Replacement
- Where
- Germany
- Volunteers
- 31 people
- Sponsor
- Heart and Brain Research Group, Germany
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Transcatheter Aortic Valve Replacement
Prognostic Factors in NOP-LBBB After TAVI
The goal of this observational study is to find prognostic factors in patients with a new-onset persistent left bundle branch block (NOP-LBBB) after transcatheter aortic valve implantation (TAVI).
- Trial name
- ProgNOP-LBBB (NCT05654792)
- Testing
- Transcatheter aortic valve implantation
- Volunteers
- 230 people
- Sponsor
- Central Hospital, Nancy, France
Aortic Valve Insufficiency, Aortic Valve Stenosis
Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight
The National Space Biomedical Research Institute is interested in learning more about heart function in space. One potential problem with long duration, manned space flight is muscle loss- including loss of heart muscle.
- Trial name
- NCT00598598
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- The Cleveland Clinic
Nephropathy
Interest of Remote Ischemic Preconditioning for Prevention of Contrast Medium-induced Nephropathy in High Risk Patients
Diagnostic imaging for vascular investigations and endovascular procedures frequently require the use of contrast medium. Besides contrast medium-induced hypersensitivity, an acute kidney injury can appear: the contrast-induced…
- Trial name
- IPC-Angio (NCT02470247)
- Testing
- Remote Ischemic Preconditioning (RIPC)
- Where
- France
- Volunteers
- 26 people
- Sponsor
- Rennes University Hospital
Valve Disease, Aortic, Mitral Regurgitation (MR)
DELINEATE-Prospective
Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart.
- Conditions
- Valve Disease, Aortic, Mitral Regurgitation (MR), Aortic Stenosis, Valvular Heart Disease
- Trial name
- DELINEATE (NCT07197736)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Amyloidosis Cardiac, Aortic Stenosis, Severe
Analysis of Calcium Score of Severe Aortic Stenosis in Patients With and Without Cardiac Amyloidosis (CAUSATIVE Study)
The concomitant presence of cardiac amyloidosis (CA) in patients with aortic stenosis (AS) may challenge the estimation of stenosis degree.
- Trial name
- CAUSATIVE (NCT06066632)
- Where
- Italy
- Volunteers
- 480 people
- Sponsor
- University Hospital of Ferrara
Hypertrophic Cardiomyopathy
Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy
Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter monitor.
- Trial name
- PRIMARy (NCT02994615)
- Where
- Canada
- Volunteers
- 19 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Hypertrophic Cardiomyopathy, Genetic Disease
Genomic Sequencing in Patients With HCM Undergoing Septal Myectomy
Investigators aim to use comparative exome and/or genome sequencing to discover causative molecular lesions for phenotypes hypothesized to be caused by somatic mutations.
- Conditions
- Hypertrophic Cardiomyopathy, Genetic Disease, Gene Product Sequence Variation
- Trial name
- NCT03043209
- Testing
- Genomic sequencing
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- The Cleveland Clinic
Hypercholesterolemia, Atherosclerosis
Dietary Phytosterols and Human Aortic Valve
This randomized controlled double-blind intervention study unravels influence of dietary plant sterols and stanols on the structure and the sterol composition of the human aortic valve.
- Trial name
- NCT00738933
- Testing
- Dietary plant stanols, Dietary plant sterols
- Where
- Finland
- Volunteers
- 60 people
- Sponsor
- University of Helsinki
Aortic Valve Disease
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic…
- Trial name
- SAPIEN3 (NCT01808287)
- Testing
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Where
- 17 sites in Canada, France and 3 more
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Type II Diabetes
Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.
- Trial name
- DIAPASON (NCT01862237)
- Testing
- Intervention
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Hospices Civils de Lyon
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.