Clinical trials: Valve Disease, Heart
Tricuspid Valve Regurgitation, Heart Valve Diseases
The TRICURE EFS Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- TRICURE EFS (NCT06506942)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 10 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- TRiCares
Mitral Valve Regurgitation
MitraClip REPAIR MR Study
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve…
- Trial name
- NCT04198870
- Testing
- MitraClip™ device implantation, Mitral Valve Repair Surgery
- Where
- 74 sites in United States, Canada and 2 more
- Volunteers
- 500 people
- Sponsor
- Abbott Medical Devices
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
Heart Diseases, Heart Valve Diseases
To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications
The objective of this study was to evaluate the effect of esketamine on intraoperative hemodynamics in patients with heart valve replacement and to mitigate postoperative pulmonary complications
- Trial name
- NCT06467513
- Testing
- Esketamine hydrochloride injection
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Zhang XIao Mei
Cardiac Valve Disease
Intrathecal Dexmedetomidine Versus Intrathecal Morphine Inpatients Undergoing Cardiac Valve Replacement Surgeries
Comparison between the effects of intrathecal morphine versus intrathecal dexmedetomidine on analgesia and respiratory function, in open heart surgery.
- Trial name
- NCT06076759
- Testing
- Intrathecal morphine or dexmedetomidine
- Volunteers
- 40 people
- Sponsor
- Assiut University
Aortic Valve Stenosis, Iron Deficiency
Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation
The aim of the open-label, randomized controlled superiority IRON TAVI trial is to investigate whether intravenous iron therapy (ferric carboxymaltose) improves Health-Related Quality of Life (HRQOL) in patients with severe…
- Conditions
- Aortic Valve Stenosis, Iron Deficiency, TAVI(Transcatheter Aortic Valve Implantation), Cardiovascular Diseases
- Trial name
- IRON TAVI (NCT07370688)
- Testing
- Intravenous ferric carboxymaltose
- Where
- Netherlands
- Volunteers
- 402 people
- Sponsor
- Erasmus Medical Center
Emergence Delirium, Postoperative Delirium
Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperative Use of a Heart-lung Machine; a Monocentric Pilot Observational Study
Basics (state of scientific knowledge): Delirium is an acute disturbance of consciousness and attention that develops over a short period of time and fluctuates in severity.
- Trial name
- MO-FA2-(TB) (NCT07276503)
- Volunteers
- 100 people
- Sponsor
- University Hospital Tuebingen
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)
Mitral Regurgitation, Mitral Valve Insufficiency
Percutaneous Mitral Valve Intervention: Predicting Improvements in Left Ventricular Performance
The purpose of this study is to assess the role of cardiac imaging combined with demographic, clinical, and biochemical parameters in predicting outcomes following percutaneous mitral valve intervention in order to facilitate…
- Trial name
- PMVI-PiP (NCT04156295)
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Aortic Valve Stenosis
Remote Ischemic Preconditioning in Aortic Valve Surgery
RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery.
- Trial name
- RIP-Valve (NCT01390129)
- Testing
- Control, Remote ischemic preconditioning
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Angers
Depression, Anxiety, Cardiac Surgery
Effect of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery
A multicenter, randomized controlled, blinded prospective study to investigate the effects of esketamine on perioperative anxiety and depression in patients undergoing cardiac valve surgery.
- Conditions
- Depression, Anxiety, Cardiac Surgery, S-ketamine
- Trial name
- NCT06608030
- Testing
- Esketamine, normal saline
- Where
- 2 sites in China
- Volunteers
- 142 people
- Sponsor
- Chinese PLA General Hospital
Tricuspid Valve Regurgitation, Heart Valve Diseases
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT06569602
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 23 sites in Germany, Greece and 4 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity…
- Trial name
- NCT06420830
- Testing
- SAPIEN 3 Ultra RESILIA Valve
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Primary Hypertension, Secondary Hypertension
HaemoDYNAMICs in Primary and Secondary Hypertension
The primary aim of the present study was to examine the haemodynamic changes in primary hypertension and secondary hypertension (renal diseases, endocrine diseases, obesity-associated hypertension) with a non-invasive…
- Conditions
- Primary Hypertension, Secondary Hypertension, Aortic Stenosis, Renal Insufficiency
- Trial name
- DYNAMIC (NCT01742702)
- Testing
- Nitroglycerin 0.25 mg (single dose, no longer given since January 2017), Salbutamol 400 µg (single dose, no longer given since January 2017), L-arginine (10 min infusion, no longer given since January 2017)
- Where
- 2 sites in Finland
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Tampere University
Aortic Valve Stenosis
RESPOND Post Market Study
The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available…
- Trial name
- RESPOND (NCT02031302)
- Testing
- Lotus Valve System
- Where
- 41 sites in Colombia, Finland and 11 more
- Volunteers
- 1,064 people
- Sponsor
- Boston Scientific Corporation
Cognitive Impairment, Older People--Abuse of
Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements
Purpose: 1. Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning) 2. Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener 3.
- Conditions
- Cognitive Impairment, Older People--Abuse of, Aortic Stenosis, Severe
- Trial name
- NCT05813353
- Where
- Netherlands
- Volunteers
- 54 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
Aortic Valve Stenosis
Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery
The goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis.
- Trial name
- SALVAGE (NCT05696145)
- Volunteers
- 170 people
- Sponsor
- Lisa Gundestrup
Tricuspid Valve Disease
Characteristics and Prognosis of Moderate or Severe Tricuspid Regurgitation
The tricuspid valve : its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified.
- Trial name
- EPIT (NCT03546231)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Aortic Stenosis, Symptomatic Aortic Stenosis
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are…
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03314857
- Testing
- SAPIEN XT THV with the NovaFlex+ delivery system
- Where
- 3 sites in China
- Volunteers
- 67 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction
This study will be evaluate the autonomic, endothelial and hemodynamic functions, inspiratory muscle strength, peripheral tissue oxygenation, peripheral and respiratory muscle architecture, and inflammatory profile of severe AS…
- Trial name
- CARE-AS-MOTION (NCT02468219)
- Testing
- cardiovascular rehabilitation program
- Where
- Brazil
- Volunteers
- 120 people
- Sponsor
- Irmandade Santa Casa de Misericórdia de Porto Alegre