Clinical trials: Transcatheter Valve Replacement
Transcatheter Aortic Valve Replacemen, Echocardiography
Echocardiography Guided TAVR (Echo TAVR)
Conventional transcatheter aortic valve replacement (TAVR) relies on fluoroscopic and contrast agents. However, in high-risk patients, exposure to ionizing radiation and contrast agents is contraindicated and undesirable.
- Trial name
- NCT07030062
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Pan Xiangbin
AV Block Complete, Tricuspid Regurgitation (TR)
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear.
- Trial name
- NCT06814574
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Aortic Valve Stenosis
The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low…
- Trial name
- 3MTAVR (NCT02287662)
- Testing
- Vancouver 3M Clinical Pathway
- Where
- Canada
- Volunteers
- 411 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
Left Ventricular Systolic Function
Predictors of Left Ventricular Systolic Function Recovery After Transcatheter Aortic Valve Replacement
Investigate the preprocedural predictors of left ventricular systolic function Recovery after TAVR
- Trial name
- NCT05069168
- Testing
- Echocardiography before and after TAVR
- Where
- Egypt
- Volunteers
- 75 people
- Sponsor
- Assiut University
Left Bundle-Branch Block, Aortic Stenosis
Study on Heart Block Risks Using Outcome-Based Modeling
This study developed a prediction model for high-grade atrioventricular block (AVB) and complete left bundle branch block (CLBBB) following transcatheter aortic valve replacement (TAVR) in Chinese patients with aortic stenosis…
- Trial name
- SAVIOR (NCT07065123)
- Testing
- The population undergoing TAVR for aortic valve stenosis with outcomes of permanent pacemaker implantation and complete left bundle branch block after surgery
- Volunteers
- 112 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Aortic Stenosis, Severe
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
- Trial name
- NCT05172960
- Testing
- SAPIEN X4 THV, SAPIEN X4S
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 1,234 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Transaxillary TAVR With Solely Echocardiography Guidance
This study aims to evaluate the safety and feasibility of performing transaxillary transcatheter aortic valve replacement (TA TAVR) guided solely by echocardiography in patients with severe aortic stenosis (AS).
- Trial name
- NCT07035847
- Testing
- Echocardiography guided TAVR
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Aortic Stenosis, Cardiogenic Shock
Transcatheter AortiC Valve Implantation in aorTic stenosIs CardiogenIc Shock
The goal of this clinical trial is to learn if acute transcatheter aortic valve implantation (TAVI) is superior to standard treatment (stabilization in an intensive care unit and TAVI subsequently) to treat cardiogenic shock in…
- Trial name
- TACTICS (NCT06638268)
- Testing
- Acute TAVI, Stabilization and subacute TAVI
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Quality of Life
Health-related QoL Following TAVI TAo, TAVI TF and AVR
The aim of the study was to evaluate short- and long-term changes in QoL in patients undergoing TAVI and to assess differences in patient QoL when using the TAVI TAo approach compared with the transfemoral approach (TAVI TF) and…
- Trial name
- NCT03583398
- Testing
- transcatheter aortic valve implantation, surgical aortic valve replacement
- Volunteers
- 97 people
- Sponsor
- Medical University of Gdansk
Aortic Valve Stenosis
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning.
- Trial name
- TAVR-Prehab (NCT03107897)
- Testing
- Pre-habilitation
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- WellSpan Health
Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation
TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries. The main questions it aims to answer are: 1.
- Conditions
- Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Commissural Alignment, Commissural Misalignment
- Trial name
- NCT06896227
- Testing
- transthoracic echocardiography
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Aortic Valve Stenosis
Engager Align Post-market Clinical Study
Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world environment.
- Trial name
- NCT02149654
- Testing
- Engager Transcatheter Aortic Valve Implantation System
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Cardiovascular Disease, Aortic Valve Stenosis
Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement
The investigators are conducting a pilot study to compare cognitive outcomes among Veterans with severe aortic valve stenosis who are scheduled to undergo either aortic valve replacement.
- Conditions
- Cardiovascular Disease, Aortic Valve Stenosis, Cognitive Assessments, Valve Surgery
- Trial name
- CAVIAR (NCT02971020)
- Testing
- Observational/Cognitive Assessment
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Minnesota Veterans Medical Research and Education Foundation
Aortic Stenosis, Coronary Artery Disease
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis.
- Conditions
- Aortic Stenosis, Coronary Artery Disease, Coronary Stenosis
- Trial name
- COMPLETE TAVR (NCT04634240)
- Testing
- Percutaneous Coronary Intervention (PCI)
- Where
- 72 sites in United States, Canada
- Volunteers
- 4,000 people
- Sponsor
- University of British Columbia
Aortic Stenosis, Ascending Aortic Dilatation
Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
The goal of this observational study is to assess the changes of ascending aortic diameter in patients undergoing transcatheter aortic valve replacement. The main questions it aims to answer are: 1.
- Conditions
- Aortic Stenosis, Ascending Aortic Dilatation, Bicuspid Aortic Valve
- Trial name
- NCT05739253
- Testing
- Transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 480 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Supra-Annular vs. Annular ValvEs for Small Annuli
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
- Trial name
- SAVE (NCT04372381)
- Testing
- Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Where
- 3 sites in United States
- Sponsor
- University of Arizona
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis
Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis
To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for…
- Trial name
- NCT02628899
- Testing
- Transfemoral TAVR, SAVR
- Where
- 11 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medstar Health Research Institute
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences