Clinical trials: TAVI
Symptomatic Severe Aortic Stenosis
Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis
The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.
- Trial name
- NCT07116551
- Testing
- Abbott BE TAVI System
- Where
- 5 sites in United States, France
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Aortic Stenosis Treated With TAVI
Zhicheng TAVR Robot
Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical…
- Trial name
- NCT07392359
- Testing
- TAVR Assistance System, TAVR by manual
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Zhicheng Medical Technology (Jiaxing) Co, Ltd
Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation
A Multimodal Strategy to Screen for and Rule-Out Delayed High-Grade Conduction Disturbances After TAVR
Electrocardiogram (ECG)-based algorithms have been proposed to guide post-TAVI conduction management; however, their ability to predict clinically relevant delayed conduction disturbances remains limited.
- Conditions
- Transcatheter Aortic Valve Implantation, Permanent Pacemaker Implantation, Right Bundle-Branch Block, Left Bundle-Branch Block
- Trial name
- LATETAVI (NCT07414485)
- Testing
- retrospective health data collection
- Where
- France
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Aortic Valve Disorder
Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for the prevention of ischemic stroke is very…
- Trial name
- TAVI-LAAC (NCT02678871)
- Testing
- Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations), WATCHMAN
- Where
- 6 sites in Germany, Italy and 2 more
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Cognitive Impairment
Impact of TAVI on Cognition, Mood and Health-related Quality of Life
In the proposed study, patients with and without embolic protection devices during Transcatheter Aortic Valve Implantation will be repeatedly examined with a comprehensive psychiatric and cognitive test battery over a…
- Trial name
- NCT04371172
- Testing
- cognitive research battery, MRI, laboratory values
- Where
- Austria
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz
Aortic Stenosis, Gender
TAVI and Gender Outcomes Aortic Stenosis Undergoing Transfemoral Transcatheter Aortic Valve Implantation.
Severe aortic stenosis (AS) is the commonest form of valvular abnormality in the developed world and transcatheter aortic valve implantation (TAVI) is now widely practiced as in many cases is the preferred treatment option over…
- Conditions
- Aortic Stenosis, Gender, Surgery
- Trial name
- NCT04915976
- Volunteers
- 14,086 people, healthy volunteers welcome
- Sponsor
- Imperial College Healthcare NHS Trust
Transcatheter Aortic Valve Replacement
Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement
This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, and procedural mortality for patients…
- Trial name
- NCT04107038
- Testing
- General Endotracheal Anesthesia, Monitored anesthesia care
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
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, Conduction Disturbances
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
The purpose of this study is to determine the incidence and predictors of high degree or complete atrioventricular block (AVB) (paroxysmal or persistent) in patients with new-onset persistent left bundle branch block (NOP-LBBB)…
- Trial name
- MARE (NCT02153307)
- Testing
- Implantable loop recorders system Reveal ICM LINQ®,
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Transcatheter Aortic Valve Implantation Prosnosis and Complications
Tryptase Level as a Marker of Complications in Transcatheter Aortic Valve Replacement
An association between mast cells and outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) has not been studied to our knowledge.
- Trial name
- TAVR (NCT03047681)
- Testing
- venous blood withdrawl
- Where
- Israel
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
Coronary Artery Bypass Grafting, Heart Valve Replacement
A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures
The purpose of this study is to develop and evaluate a frailty-specific prehabilitation program for patients awaiting cardiac surgeries/procedures.
- Conditions
- Coronary Artery Bypass Grafting, Heart Valve Replacement, Transcatheter Aortic Valve Implantation, Frailty
- Trial name
- PREHAB (NCT06323317)
- Testing
- Multi-component exercise programme, Structured preoperative education, Nutritional optimization
- Where
- Hong Kong
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
Aortic Valve Stenosis
Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access
Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System
- Trial name
- Portico ALT (NCT03056573)
- Testing
- Transaortic TAVR Implant, Subclavian /Axillary TAVR implant
- Where
- 10 sites in Denmark, Germany and 3 more
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Transcatheter Aortic Valve Replacement
CT TAVR Abdomen Study
A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or…
- Trial name
- CT TAVR (NCT05758701)
- Testing
- Iodinated Contrast Agent (Omnipaque), Dual Energy CT
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Glutathione Peroxidase Activity, Aortic Stenosis
GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR
The aim of this project is to investigate the association of glutathione peroxidase (GPx) and severe aortic stenosis (AS), as well as the impact of transcatheter aortic valve replacement (TAVR) on GPx activity post-procedure.
- Conditions
- Glutathione Peroxidase Activity, Aortic Stenosis, Transcatheter Aortic Valve Replacement
- Trial name
- NCT04268160
- Testing
- Blood draw to measure GPx activity, Blood draw to measure SOD activity, Blood draw to measure Lp(a) levels
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Florida
TAVI
Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI)
Investigate the predictors of conduction abnormalities after TAVI, and in particular the predictive role of the tilt-angle during implantation.
- Trial name
- NCT04083040
- Testing
- transcatheter aortic valve implantation
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Assiut University
Valvular Heart Disease, Treatment Adherence and Compliance
Valvular Heart Disease in Jiangxi Province
Study Title: A real-world study of valvular heart disease in Jiangxi Province Research Objectives: ① Main objectives: To examine the current incidence of valvular heart disease in Jiangxi Province, to establish a "Formal…
- Trial name
- JXVD (NCT05523193)
- Testing
- Formal treatment model
- Where
- China
- Volunteers
- 1,052 people, healthy volunteers welcome
- Sponsor
- Xiao Huang
Conduction Disturbances, Transcatheter Aortic Valve Replacement
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients.
- Conditions
- Conduction Disturbances, Transcatheter Aortic Valve Replacement, Permanent Pacemaker Implantation
- Trial name
- PROMOTE (NCT04139616)
- Where
- Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Left Bundle Branch Block, Transcatheter Aortic Valve Replacement
HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients
TAVI induced LBBB is a complication that occurs between 7 and 65 % of the cases, numbers that differ considerably between devices.
- Conditions
- Left Bundle Branch Block, Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation
- Trial name
- HESITATE (NCT02659137)
- Testing
- HV measurement
- Where
- Netherlands
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
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
TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder
Biomarkers of Inflammation and Fibrosis in Conduction Disorders After TAVI
Prediction of conduction disorders (CDs) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) is an important and complex process with a significant impact on patient outcomes.
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Conduction Disorder, Aortic Stenosis, Permanent Pacemaker Implantation
- Trial name
- NCT07201363
- Testing
- Biomarkers of inflammation and fibrosis in pre-procedural serum blood samples, Transthoracic echocardiography with myocardial deformation analysis and staging according to the extent of cardiac damage related to AS
- Where
- Croatia
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Clinical Hospital Center Rijeka