Clinical trials: Transcatheter Valve Replacement
Aortic Valve Stenosis
TranScatheter Aortic Valve RepLacement System US Feasibility Trial
A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair.
- Trial name
- SALUS (NCT01932099)
- Testing
- Transcatheter aortic valve replacement
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Direct Flow Medical, Inc.
Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability
Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients
Within 30 minutes before anesthesia, acupoint electrical stimulation at different frequencies were applied at Neiguan, Jian Shi, and Baihui.
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR), Hemodynamic Stability, Anesthesia Induction, Electro-acupuncture
- Trial name
- FRESH-T (NCT07365345)
- Testing
- electrical acupoint stimulation
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Air Force Military Medical University, China
High-surgical Risk Patients with Severe Tricuspid Regurgitation
Characterization and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement
The TRI-RECRUIT Study was conducted of 340 consecutive patients for TTVR screening using LuX-Valve via the trans-jugular vein approach at seven cardiac centers.
- Trial name
- The TRI-RECRUI (NCT06862765)
- Testing
- transcatheter tricuspid valve replacement
- Where
- 8 sites in China
- Volunteers
- 340 people
- Sponsor
- Xijing Hospital
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System - The Engager European Pivotal Trial
The purpose of the study is to evaluate the safety and clinical performance of the Engager Transcatheter Aortic Valve Implantation System in patients with severe aortic valve stenosis who are at high risk for surgical valve…
- Trial name
- NCT01348438
- Testing
- Medtronic Engager Transcatheter Aortic Valve Implantation System
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Complete Heart Block, High Degree Second Degree Atrioventricular Block
Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement (Left Bundle BRAVE)
The purpose of the study is to investigate the superiority of chronic left bundle branch area pacing compared to traditional right ventricular (RV) septal pacing in patients with high-grade conduction disease after transcatheter…
- Conditions
- Complete Heart Block, High Degree Second Degree Atrioventricular Block, Pacemaker-Induced Cardiomyopathy, Aortic Valve Stenosis
- Trial name
- NCT05541679
- Testing
- Right ventricular septal pacing followed by left bundle branch area pacing, Left bundle branch area pacing followed by right ventricular septal pacing
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- Main Line Health
Aortic Stenosis
PRessure-based Evaluation of Disease Improvement in the Course of TAVI
The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90)…
- Trial name
- PREDIC-TAVI (NCT07509554)
- Testing
- Transcatheter aortic valve replacement (TAVR / TAVI)
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Tricuspid Valve Regurgitation, Heart Valve Diseases
2019-06 TRISCEND Study
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT04221490
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 20 sites in United States, Canada and 2 more
- Volunteers
- 228 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Disease
Hamburg TranscathEteR Mitral Valve REplacement RegiStry
The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that…
- Trial name
- HERMES (NCT04914468)
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Degenerative Mitral Regurgitation
CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation
This is a prospective, multi-center, single-arm study to assess the safety and effectiveness of Microport CardioFlow Transcatheter Mitral Valve Replacement system in the treatment of moderate to severe or severe degenerative…
- Trial name
- NCT07857343
- Testing
- Microport CardioFlow Mitral Valve Replacement System
- Where
- 3 sites in China
- Volunteers
- 152 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
This is an early study of a catheter-based minimally invasive procedure called SESAME to slice thick heart muscle as described below.
- Conditions
- Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction, Systolic Anterior Motion
- Trial name
- NCT07806149
- Testing
- SESAME Procedure
- Where
- 8 sites in United States
- Volunteers
- 200 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Aortic Valve Stenosis, Bicuspid Aortic Valve
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVE-IT (NCT06817148)
- Testing
- transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR)
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Cedars-Sinai Medical Center
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
Tricuspid Regurgitation (TR)
LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd.
- Trial name
- NCT07705594
- Testing
- Transvenous Tricuspid Valve System implantation + OMT, OMT
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Jenscare Scientific
Aortic Stenosis, Severe
China S3 PMS: SAPIEN 3 China Post Market Registry Study
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
- Trial name
- NCT05168826
- Testing
- SAPIEN 3 Transcatheter Heart Valve
- Where
- 14 sites in China
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Transcatheter Aortic Valve Replacement, Cardiac Valve Annuloplasty
Assessment of Clinical Onset of IV Heparin in Interventional Cardiology and Cardiac Surgery
The efficiency and promptness of heparin anticoagulation is necessary during the structural heart procedures to minimize time from insertion of cannulae to valve deployment in cardiac surgery.
- Trial name
- ACTPOC (NCT04785885)
- Testing
- iStat Handheld Blood Analyzer, Hemochron
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Rhode Island Hospital
Aortic Stenosis
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the…
- Trial name
- SAVI TF (NCT02306226)
- Volunteers
- 1,000 people
- Sponsor
- Symetis SA
Tricuspid Regurgitation
Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the…
- Trial name
- TRIPLACE (NCT06033274)
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 31 sites in United States, Canada and 6 more
- Volunteers
- 800 people
- Sponsor
- Montefiore Medical Center
Aortic Stenosis
Promoting Shared Decision Making for Severe Aortic Stenosis
The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are: Do patient decision aids and clinician skills training course…
- Trial name
- IMPACT SDM (NCT06171737)
- Testing
- Decision Aid, Shared Decision Making Skills Training
- Where
- 8 sites in United States
- Volunteers
- 1,300 people
- Sponsor
- Massachusetts General Hospital
Tricuspid Regurgitation (TR), Valvular Heart Diseases
Robotic Transjugular Transcatheter Tricuspid Valve Replacement
Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide.
- Conditions
- Tricuspid Regurgitation (TR), Valvular Heart Diseases, Transcatheter Valve Replacement
- Trial name
- Robotic Lux (NCT07516145)
- Testing
- Transcatheter tricuspid valve replacement
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong