Clinical trials: Valve-in-valve Procedures, open to volunteers
Respiratory Failure, Communication Disorders
Early Speaking Valve in Ventilator Weaning: Effects on Communication, Depression, and Quality of Life
This study evaluates the impact of early tracheostomy speaking valve intervention on communication ability, depression levels, and quality of life in ventilator-dependent patients during the weaning phase.
- Conditions
- Respiratory Failure, Communication Disorders, Depression, Quality of Life
- Trial name
- NCT07005596
- Testing
- Passy-Muir Speaking Valve, Standard Non-Verbal Communication Methods
- Volunteers
- 70 people
- Sponsor
- Far Eastern Memorial Hospital
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
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
Hypertrophic Cardiomyopathy (HCM)
The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction
This study is a prospective interventional cohort study aimed at evaluating the therapeutic efficacy and clinical utility of Mavacamten-a targeted myosin inhibitor specifically developed for obstructive hypertrophic…
- Trial name
- BRAVE-HCM (NCT07103655)
- Testing
- mavacamten, Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol, diltiazem
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Heart Failure, Aortic Stenosis
The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis
The role of cardiac mechanics, circulating biomarkers and frailty in predicting outcomes in patients with aortic stenosis after aortic valve replacement (SCRABLES -The 2-Parts Study) Part I: Observational study to characterize…
- Trial name
- SCRABLES (NCT02856620)
- Testing
- Observational only
- Where
- Canada
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Christine Henri
Cognitive Decline, Stroke
Identification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly
Over the past ten years, the number of endovascular procedures has increased by 5% per year in Europe with the development of interventional cardiology, such as percutaneous coronary angioplasty, aortic valve replacements (TAVR)…
- Trial name
- METHYSTROKE (NCT02972008)
- Where
- France
- Volunteers
- 542 people
- Sponsor
- University Hospital, Lille
AORTIC VALVE DISEASES, Valve-in-valve Procedures
Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.
This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic…
- Conditions
- AORTIC VALVE DISEASES, Valve-in-valve Procedures, Surgical Valve Replacement, Valve Disease, Aortic
- Trial name
- REVIVAL (NCT07524595)
- Testing
- Hydra THV Series, Sapien THV Series and MyVal THV Series
- Where
- Ireland
- Volunteers
- 111 people
- Sponsor
- National University of Ireland, Galway, Ireland
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 Valve Regurgitation
Early Aortic vaLve surgEry Versus wAtchful waitiNg Strategy in Severe Asymptomatic aOrtic reguRgitation
The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with…
- Trial name
- ELEANOR (NCT05438862)
- Testing
- State of art aortic valve surgery
- Where
- 8 sites in Belgium, Czechia and 1 more
- Volunteers
- 217 people
- Sponsor
- Na Homolce Hospital
Mitral Stenosis
Assessment of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With Mitral Stenosis
Heart valve diseases are the most common cause of mortality and morbidity after coronary artery disease, hypertension, and heart failure.
- Trial name
- NCT07394998
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Gazi University
Degenerative Aortic Valve Disease
REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke…
- Trial name
- REPEAT (NCT07462624)
- Testing
- Transfemoral transcatheter valve-in-valve implantation, Surgical redo aortic valve replacement
- Where
- Germany
- Volunteers
- 890 people
- Sponsor
- Heart Center Leipzig - University Hospital
Delirium - Postoperative, Sleep Problems
Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery
This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in adult patients undergoing…
- Conditions
- Delirium - Postoperative, Sleep Problems, CABG, Valve Surgery
- Trial name
- NCT06777342
- Testing
- Cognitive behavioral therapy intervention, Melatonin intervention
- Volunteers
- 1,281 people
- Sponsor
- Yan Fuxia
Intellectual Disability, Neurodevelopmental Disorders
Physical Activity and Community EmPOWERment Project
Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer's Disease…
- Conditions
- Intellectual Disability, Neurodevelopmental Disorders, Autism Spectrum Disorder, Down Syndrome
- Trial name
- PACE (NCT06740162)
- Testing
- PACE Program
- Where
- 2 sites in United States
- Volunteers
- 376 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis
Preliminary Exploration of Factors Affecting Complete Hemostasis and Supine Time After Removal of Femoral Arterial Sheath in ICU Patients
Background:Following cardiac catheterization and arterial sheath removal, manual compression is applied until bleeding stops, after which a compression belt is used.
- Conditions
- Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis, Coronary Artery Disease, Percutaneous Coronary Intervention
- Trial name
- NCT07469397
- Testing
- Direct Inspection, medical records browsing
- Where
- Taiwan
- Volunteers
- 157 people
- Sponsor
- National Taiwan University Hospital
Severe Aortic Valve Disease, Aortic Valve Replacement (AVR)
Comparative Research of Y-Incision vs. Standard Techniques for Aortic Root EnLargement
Abstract Background: Aortic valve replacement (AVR) is crucial for patients with severe aortic valve disease. However, managing those with a small aortic annulus (SAA, i.e., annulus diameter < 22 mm) is challenging because…
- Conditions
- Severe Aortic Valve Disease, Aortic Valve Replacement (AVR), Small Aortic Annulus
- Trial name
- CRYSTAL (NCT07368322)
- Testing
- Y incision Technique (YIT), Standard surgical enlargement techniques
- Where
- Israel
- Volunteers
- 90 people
- Sponsor
- willner nadav MD
Bicuspid Aortic Valve Disease
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVERS (NCT07413965)
- Testing
- Transcatheter Aortic Valve Replacement, the open chest surgery to replace the aortic valve
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Cedars-Sinai Medical Center
Low Flow, Low Gradient Aortic Stenosis
Transcatheter Aortic Valve Replacement in Severe Low Flow, Low Gradient Aortic Stenosis
LOW-TAVR is a real-world, retrospective and prospective, multicenter Italian registry aimed at evaluating the characteristics and clinical outcomes of patients with severe low flow, low gradient aortic stenosis undergoing…
- Trial name
- LOW-TAVR (NCT06589063)
- Testing
- Transcatheter aortic valve replacement
- Where
- Italy
- Volunteers
- 1,350 people
- Sponsor
- University of Salerno
Aortic Stenosis
Prediction of Long-term Outcome in Aortic Stenosis After Valve Intervention
Patients with severe aortic stenosis accepted for transcatheter intervention or open surgery are included before the intervention, and then followed up with clinical visits during the first year after intervention.
- Trial name
- NCT05629104
- Testing
- There is no intervention since it is an observational study patients are treated according to clinical praxis
- Where
- Sweden
- Volunteers
- 300 people
- Sponsor
- Uppsala University
Aortic Valve Insufficiency
Results of the Aortic Valve Reconstruction in Children
Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system.
- Trial name
- NCT04162444
- Testing
- Physical examination, The Ross Classification for Heart Failure in Children, The Aristotle score
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- National Medical Research Center for Children's Health, Russian Federation
Prehabilitation, Cardiac Surgery
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Rationale Cardiac surgery via median sternotomy carries an elevated risk of postoperative complications and delayed functional recovery.
- Conditions
- Prehabilitation, Cardiac Surgery, Risk Assesment, Aortic Valve
- Trial name
- PREPA-STER (NCT07893184)
- Testing
- Physical Prehabilitation Intervention
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Maastricht University Medical Center