Clinical trials: Aortic Valve Disease
Aortic Valve Disease, Aortic Valve Replacement
Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)
In this study, the investigators will evaluate the feasibility and potential efficacy of programs to improve functional outcomes after minimally-invasive transcatheter aortic valve replacement (TAVR).
- Trial name
- OPTIMAL (NCT06106451)
- Testing
- Standard of Care plus Enhanced Patient Education, Motivational Interviewing Intervention, Home-Based Activity Program plus Motivational Interviewing Intervention
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Johns Hopkins University
Sudden Cardiac Arrest, Sudden Arrhythmic Death Syndrome
Hearts in Rhythm Organization (HiRO)National Registry and Bio Bank
The Hearts in Rhythm Organization (HiRO) is a national network of Canadian researchers/clinicians, working towards a better understanding of the rare genetic causes of sudden cardiac death (SCD).
- Conditions
- Sudden Cardiac Arrest, Sudden Arrhythmic Death Syndrome, Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), Long QT Syndrome (LQTS)
- Trial name
- HiRO (NCT04189822)
- Where
- Canada
- Volunteers
- 10,000 people
- Sponsor
- University of British Columbia
Coronary Artery Disease, Arrhythmias, Cardiac
Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics
The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear.
- Conditions
- Coronary Artery Disease, Arrhythmias, Cardiac, Heart Valve Diseases, Aortic Dissection
- Trial name
- PROSPECT (NCT06001073)
- Testing
- Observational; No Interventions were given.
- Where
- China
- Volunteers
- 25,000 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII S3HR/NR7 (NCT03222141)
- Testing
- TAVR Implantation of the THV Prosthesis
- Where
- 40 sites in United States, Canada
- Volunteers
- 583 people
- Sponsor
- Edwards Lifesciences
Stenosis, Regurgitation, Aortic
Dokimos Plus Aortic Valve Implant in 80 Patients Diagnosed With a Heart Valve Disease and Requiring Valve Replacement
This study intends to reinforce the current clinical information regarding safety and efficacy of the Dokimos Plus aortic valve prosthesis in patients in whom an aortic valve replacement with a bioprosthesis has been indicated.
- Trial name
- NCT04370041
- Testing
- Dokimos Plus aortic valve
- Where
- 3 sites in Spain
- Volunteers
- 80 people
- Sponsor
- Swan Medical S. L.
Aortic Valve Stenosis, Aortic Valve Insufficiency
Clinical Investigation for the Foldax Tria Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the Foldax Tria Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- NCT06192706
- Testing
- Foldax Tria Aortic Valve
- Where
- 10 sites in India
- Volunteers
- 50 people
- Sponsor
- Foldax, Inc
Prader-Willi Syndrome, PWS-like Syndrome
GROWing Up With Rare GENEtic Syndromes
Introduction Rare complex syndromes Patients with complex genetic syndromes, by definition, have combined medical problems affecting multiple organ systems, and intellectual disability is often part of the syndrome.
- Conditions
- Prader-Willi Syndrome, PWS-like Syndrome, Silver Russel Syndrome, Congenital Hypopituitarism
- Trial name
- GROW UR GENES (NCT04463316)
- Testing
- Retrospective file studies
- Where
- Netherlands
- Volunteers
- 600 people
- Sponsor
- dr. Laura C. G. de Graaff-Herder
Aortic Stenosis
Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System
To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical…
- Trial name
- NCT03043404
- Testing
- Transcatheter aortic valve replacement
- Where
- 2 sites in Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis, Aortic Valve Regurgitation
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Data on valve performance following ViV-TAVR has usually been obtained with the use of Doppler-echocardiography. However, some reports have shown significant discordances in the evaluation of mean transvalvular gradient between…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure
- Trial name
- ECHOCATH (NCT05459233)
- Testing
- Doppler-echocardiography, Invasive hemodynamic measurements
- Where
- 7 sites in United States, Canada
- Volunteers
- 310 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Postoperative Atrial Fibrillation
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF).
- Trial name
- NCT02132767
- Testing
- Amiodarone, DC-cardioversion, Rate Control
- Where
- 23 sites in United States, Canada
- Volunteers
- 523 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
Danon Disease
A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease
This is a single arm Phase 2 trial to evaluate the efficacy and safety of RP-A501, a recombinant adeno-associated virus serotype 9 (rAAV9) vector containing the human lysosome-associated membrane protein 2 isoform B (LAMP2B)…
- Trial name
- NCT06092034
- Testing
- RP-A501
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Heart Valve Disease
Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
Evaluation of decellularized human heart valves for aortic heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and…
- Trial name
- ARISE (NCT02527629)
- Testing
- Decellularized human heart valves
- Where
- 8 sites in Belgium, Germany and 5 more
- Volunteers
- 144 people
- Sponsor
- corlife
Aortic Stenosis
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
- Trial name
- COMPARE-TAVI (NCT06470022)
- Testing
- Medtronic Evolut FX, Edwards Sapien 3 Ultra Resilia
- Where
- Denmark
- Volunteers
- 1,370 people, healthy volunteers welcome
- Sponsor
- Christian Juhl Terkelsen
Aortic Valve Disease, Coronary Artery Disease (CAD)
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery.
- Trial name
- Custodiol-AV (NCT02098772)
- Testing
- Custodiol-N, Custodiol
- Where
- 6 sites in Germany
- Volunteers
- 530 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Aortic Stenosis
Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography
Calcific aortic stenosis (AS) (formerly "senile" or "degenerative") is a frequent disease of heart valves and is characterized by a thickness and calcification of leaflets with a significant increase of the pressure gradient…
- Trial name
- TAVI (NCT04231201)
- Where
- Belgium
- Volunteers
- 135 people
- Sponsor
- Erasme University Hospital
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
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