Clinical trials: Stenoses, Aortic
Hypertrophic Obstructive Cardiomyopathy
Transapical Beating-Heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy: a Multi-Center Study
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy.
- Trial name
- NCT05957419
- Testing
- Transapical beating-heart septal myectomy
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xiang Wei
Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic
Association of Insulin Resistance and FGF21 on Cardiac Function in Pediatric Dilated Cardiomyopathy
This study will investigate whether there is an association between insulin resistance and cardiac function in children with dilated or hypertrophic cardiomyopathy.
- Conditions
- Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Insulin Resistance
- Trial name
- NCT04222101
- Testing
- Oral glucose tolerance test
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Le Bonheur Children's Hospital
Aortic Valve Stenosis, Diastolic Dysfunction
Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
The purpose of this study is to examine the impact of early surgery in patients with asymptomatic severe aortic valve stenosis with signs of subclinical LV dysfunction despite preserved LVEF, with a watchfull waiting approach.
- Trial name
- DANAVR (NCT03972644)
- Testing
- Aortic valve replacement
- Where
- Denmark
- Volunteers
- 1,700 people
- Sponsor
- Odense University Hospital
Hypertrophic Cardiomyopathy
Paced Dyssynchrony and Myocardial Perfusion IN apiCal Hcm
Hypertrophic cardiomyopathy (HCM) is the most common inherited heart disease. A relatively common subgroup of HCM patients have apical HCM - a type of heart muscle disease that causes abnormal muscle thickening towards the tip…
- Trial name
- PINCHcm (NCT04231032)
- Testing
- Asynchronous dual chamber pacing (DOO) with paced ventricular activation, Asynchronous atrial pacing (AOO) with intrinsic ventricular activation
- Where
- United Kingdom
- Volunteers
- 11 people
- Sponsor
- Barts & The London NHS Trust
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 Stenosis
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
- Trial name
- PROGRESS (NCT02987894)
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 23 sites in Canada, Germany and 2 more
- Volunteers
- 500 people
- Sponsor
- Symetis SA
Aortic Stenosis, Severe
Selection of Transcatheter Heart vaLve With Intermediate Sizing in Patients With Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Replacement
Transcatheter aortic valve implantation (TAVI) has evolved into a standard therapy for severe aortic stenosis across all surgical risk profiles, supported by pivotal trials in high- and low-risk populations.
- Trial name
- SELECT TAVR (NCT07689279)
- Testing
- Transcatheter Heart Valve
- Volunteers
- 604 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
Aortic Stenosis
Implantable Sensor in Aortic Stenosis
To establish the relationship between a panel of biological markers obtained from the REVEAL Linq device and exercise performance as judged by cardiopulmonary exercise testing
- Trial name
- ISAS (NCT06826183)
- Testing
- REVEAL Linq device
- Where
- United Kingdom
- Volunteers
- 17 people
- Sponsor
- Barts & The London NHS Trust
Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
- Trial name
- TIAMAR (NCT05310461)
- Testing
- Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement, Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention
- Where
- 3 sites in Switzerland
- Volunteers
- 80 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Stenosis, Cardiac Amyloidosis
Targeted Testing for ATTR Among Aortic Stenosis Patients-Pilot
Our ultimate goal is to design a multi-center randomized trial to test the hypothesis that targeted testing for transthyretin cardiac amyloid (ATTR) will improve survival and health status among aortic stenosis patients who…
- Trial name
- NCT04363294
- Testing
- PYP scan
- Sponsor
- University of Texas Southwestern Medical Center
Hypertrophic Cardiomyopathy
A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM)
This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (oHCM) and as multiple doses in adults with…
- Trial name
- NCT06347159
- Testing
- EDG-7500
- Where
- 21 sites in United States
- Volunteers
- 79 people
- Sponsor
- Edgewise Therapeutics, Inc.
Hypertrophic Cardiomyopathy
The Efficacy and Mechanism of Trientine in Patients With Hypertrophic Cardiomyopathy
This research study has been designed to test whether a drug called trientine dihydrochloride (also called Cufence) reduces heart muscle thickening, improves exercise capacity, improves heart function and reduces abnormal heart…
- Trial name
- TEMPEST (NCT04706429)
- Testing
- Trientine
- Where
- 7 sites in United Kingdom
- Volunteers
- 154 people
- Sponsor
- Manchester University NHS Foundation Trust
Stroke, Aortic Valve Stenosis
INTERvention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi)
The study aims to evaluate the processes of a pilot single-centre randomised controlled trial (RCT) of carbon-dioxide flushing of transcatheter aortic valves (TAVI-CO2) versus standard saline flushing of valves (TAVI-S) and…
- Conditions
- Stroke, Aortic Valve Stenosis, Silent Cerebral Infarct, Vascular Brain Injury
- Trial name
- INTERCEPTavi (NCT05146037)
- Testing
- CO2 and saline flushing, Saline flushing
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Obstructive Hypertrophic Cardiomyopathy
Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM).
- Trial name
- EXPLORER-HCM (NCT03470545)
- Testing
- mavacamten
- Where
- 71 sites in United States, Belgium and 11 more
- Volunteers
- 251 people
- Sponsor
- MyoKardia, Inc.
Aortic Valve Stenosis, Endovascular Aortic Valve Replacement
Heart Leaflet Technologies Valve Study
The study will be conducted in patients who are undergoing surgical aortic valve replacement on cardiopulmonary bypass. Following surgical access of the native aortic valve and prior to removal of the valve, the native valve will…
- Trial name
- HLT (NCT00710775)
- Testing
- surgical replacement of the aortic stenotic valve
- Where
- Italy
- Volunteers
- 7 people
- Sponsor
- Centro Cardiologico Monzino
Severe Aortic Stenosis
SOURCE XT REGISTRY
This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that…
- Trial name
- NCT01238497
- Testing
- TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
- Where
- 104 sites in Austria, Belgium and 16 more
- Volunteers
- 2,954 people
- Sponsor
- Edwards Lifesciences
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes
This is a pilot study in which we will aim to demonstrate successful execution of the imaging protocol and to make observations regarding the calcification activity as measured by 18F-NaF PET/CT and any correlation to 1) valve…
- Trial name
- NCT03095313
- Testing
- 18F-NaF
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Valve Stenosis
Desflurane-induced Myocardial Protection
This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery.
- Trial name
- NCT02019797
- Testing
- Desflurane
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Nobuyuki Katori
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