Clinical trials: Valve-in-valve Procedures
Aortic Valve Stenosis, Cardiovascular Diseases
Comparison of TAVR With SAVR in Younger Low Surgical Risk Patients With Severe Aortic Stenosis
A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases
- Trial name
- NOTION-2 (NCT02825134)
- Testing
- Transcatheter aortic valve replacement, Surgical aortic valve replacement
- Where
- 9 sites in Denmark, Finland and 3 more
- Volunteers
- 376 people
- Sponsor
- Ole De Backer
Irreversible Pulpitis, Reversible Pulpitis
In Vivo Pulp Thermal Changes During Different Slenderization Techniques
The goal of this study is to learn about the temperature rise inside the living part of a tooth (the pulp) during different ways of removing a small amount of enamel (the hard outer layer of the tooth), a procedure called…
- Conditions
- Irreversible Pulpitis, Reversible Pulpitis, Thermal Injury, Pulp Hyperemia
- Trial name
- IPR (NCT07391124)
- Testing
- High-Speed Air-Driven Drill (Airotor and Bur), Orthodontic IPR Kit (Oscillating System)
- Where
- Pakistan
- Volunteers
- 30 people
- Sponsor
- Armed Forces Institute of Dentistry, Pakistan
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
Anesthesia, Analgesia
Transversus Abdominis Plan (TAP) Block for Transcatheter Aortic Valve Implantation (TAVI)
Hemodynamic stability is the main goal of the anesthetic method during Transcatheter Aortic Valve Implantation (TAVI). Pain during the procedure may cause patients to move therefore hemodynamic instability.
- Conditions
- Anesthesia, Analgesia, Block, Aortic Valve Stenosis
- Trial name
- NCT06762288
- Testing
- Ultrasound, Local anesthesia and sedation
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Istanbul University - Cerrahpasa
Cardiac Surgical Procedures
Buckberg vs Del Nido in Isolated Aortic Valve Replacement
The study compares safety and efficacy of the Del Nido cardioplegic solution, comparing it with the Buckberg cardioplegic solution in single aortic valve replacement procedures.
- Trial name
- NCT04259515
- Testing
- Del Nido, Buckberg
- Where
- 2 sites in Spain
- Volunteers
- 286 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Haemoptysis
Endobronchial Valves in Inoperable Patients With Haemoptysis
Massive haemoptysis is a life-threatening condition which is commonly seen in patients who have previously had pulmonary tuberculosis.
- Trial name
- NCT02816229
- Testing
- Insertion of endobronchial valve
- Volunteers
- 20 people
- Sponsor
- University of Stellenbosch
Aortic Stenosis, TAVI
Echo-Guided vs Fluoroscopy-Guided Transcatheter Aortic Valve Replacement in Patients With Aortic Stenosis（ECHO-TAVR）
Aortic stenosis (AS) is a common valvular heart disease whose prevalence increases markedly with age-approximately 2-4% in individuals aged 65 years and older, and up to 3.4% for severe AS in those over 75.
- Conditions
- Aortic Stenosis, TAVI, TAVI(Transcatheter Aortic Valve Implantation)
- Trial name
- ECHO-TAVR (NCT07317804)
- Testing
- Echocardiographic guidance, Fluoroscopic guidance
- Where
- China
- Volunteers
- 212 people
- Sponsor
- China National Center for Cardiovascular Diseases
Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities
- Trial name
- NCT02987387
- Testing
- SAPIEN XT THV
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Edwards Lifesciences
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
Aortic Valve Disease
CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics
The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.
- Trial name
- NCT00619151
- Testing
- Top Hat, Regent
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Sorin Group USA, Inc.
Coronary Artery Bypass Grafting, Heart Valve Disease
LLM-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Cardiac Surgery Patients
This is a single-center, prospective, randomized, open-label, parallel-controlled clinical study to evaluate the effectiveness of a large language model (LLM)-based intelligent health management assistant in the life-cycle health…
- Conditions
- Coronary Artery Bypass Grafting, Heart Valve Disease, Aortic Aneurysm, Aortic Dissection
- Trial name
- cFT-LLM (NCT07521488)
- Testing
- LLM-Based Intelligent Health Management Assistant
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Beijing Anzhen Hospital
Aortic Stenosis Treated With TAVI, Sedation; Aged; Hemodynamics
High Flow Nasal Oxygenation in Transcatheter Aortic Valve Replacement Procedures. TAVR-Highflow II
Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with aortic valve disease. TAVR is a less invasive treatment compared to the conventional surgical approach through median sternotomy.
- Trial name
- NCT07059728
- Testing
- Oxygen therapy during sedation provided via high nasal cannulae (60L/min at 60% FiO2), Oxygen therapy during sedation delivered via nasal cannulae at 5L/min
- Where
- Spain
- Volunteers
- 452 people
- Sponsor
- Hospital Clinic of Barcelona
Atrial Fibrillation, Atrial Flutter
Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism and Thrombosis
- Trial name
- SAFE-VEIN (NCT04632641)
- Testing
- Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES, Figure 8 Suture - LARGE-BORE PROCEDURES
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Wake Forest University Health Sciences
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
Acute Coronary Syndromes
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a…
- Trial name
- NCT02415400
- Testing
- Apixaban, vitamin K antagonist, Acetylsalicylic acid
- Where
- 626 sites in United States, Argentina and 35 more
- Volunteers
- 4,614 people
- Sponsor
- Bristol-Myers Squibb
Structural Valve Deterioration, Structural Valve Degeneration
The ReTAVI Prospective Observational Registry
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a…
- Conditions
- Structural Valve Deterioration, Structural Valve Degeneration, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction
- Trial name
- NCT05601453
- Testing
- Elective redo transcatheter aortic valve implantation (redo-TAVI)
- Where
- 62 sites in Austria, Canada and 9 more
- Volunteers
- 250 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Heart Failure, Valvulopathy
Optimization of Heart Failure (HF) Medical Therapy After Transcatheter Valve Intervention (TVI) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF)
This trial is a single-center, open-label, randomized study designed to assess the impact of a rapid up-titration of Guideline-Directed Medical Therapy (GDMT) on heart failure with reduced ejection fraction (HFrEF) patients…
- Conditions
- Heart Failure, Valvulopathy, Aortic Stenosis, Aortic Regurgitation Disease
- Trial name
- OPTIMAV (NCT06667128)
- Testing
- Rapid Uptitration of Guideline-Directed Medical Therapy, Elecsys® NT-proBNP - Roche Diagnostics, Rapid Up-Titration GDMT Group with Hospital Monitoring
- Where
- Italy
- Volunteers
- 160 people
- Sponsor
- IRCCS Ospedale San Raffaele
Mitral Valve Insufficiency
Surgical Treatment of Ischemic Mitral Regurgitation
The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact on heart failure and progress of mitral…
- Trial name
- TIME (NCT01368575)
- Testing
- CABG, CABG combined with MV repair with remodeling annuloplasty rigid ring, CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus
- Where
- Russia
- Volunteers
- 420 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Aortic Valve Surgery
10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure
To compare mechanic and thermic stability of pericardium fixated either with 0.6% glutaraldehyde for 10 minutes or with 0.6% glutaraldehyde for 20 minutes
- Trial name
- 10vs20-OZAKI (NCT03667235)
- Testing
- Treatment of human pericardium with glutaraldehyde in OZAKI procedure, Treatment of human aortic valve tissue with glutaraldehyde
- Where
- Switzerland
- Volunteers
- 6 people
- Sponsor
- University Hospital, Basel, Switzerland
Atrial Fibrillation, Coronary Artery Disease
Prospective Project to Identify Biomarkers of Morbidity and Mortality in Cardiovascular Interventional Patients
The objective of CAREBANK study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease, Aortic Valve Stenosis, Aortic Valve Disease
- Trial name
- CAREBANK (NCT03444259)
- Testing
- Cardiac surgery
- Where
- Finland
- Volunteers
- 1,001 people
- Sponsor
- University of Turku