Clinical trials: Transcatheter Valve Replacement
Transcatheter Aortic Valve Replacement
Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System
This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using…
- Trial name
- NCT05202977
- Testing
- SinocrownTM Transcatheter Aortic Valve Replacement System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Heart Valve Disease, Mitral Valve (MV) Regurgitation
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging…
- Conditions
- Heart Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis
- Trial name
- VALVE-COMPASS (NCT07267117)
- Where
- 15 sites in China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Transcatheter Aortic Valve Replacement
Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).
- Trial name
- GALILEO (NCT02556203)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Acetylsalicylic Acid (ASA), Clopidogrel
- Where
- 140 sites in United States, Austria and 15 more
- Volunteers
- 1,653 people
- Sponsor
- Bayer
Valvular Heart Disease
The PROTEMBO C Trial
The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve…
- Trial name
- NCT04618718
- Testing
- cerebral embolic protection during TAVR
- Where
- 8 sites in Germany, Latvia and 1 more
- Volunteers
- 64 people
- Sponsor
- Protembis GmbH
Severe Aortic Valve Stenosis
The PROTEMBO Trial
The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and…
- Trial name
- NCT05873816
- Testing
- ProtEmbo - Cerebral Embolic Protection, Sentinel - Cerebral Embolic Protection
- Where
- 20 sites in United States, Germany and 1 more
- Volunteers
- 284 people
- Sponsor
- Protembis GmbH
Aortic Stenosis
Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR
TEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil.
- Trial name
- TEAm-BR (NCT04067089)
- Testing
- TAVR - Transcatheter aortic valve replacement, Surgical aortic valve replacement
- Where
- Brazil
- Volunteers
- 126 people
- Sponsor
- Hospital do Coracao
Aortic Stenosis, Aortic Valve Stenosis
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics)…
- Trial name
- NCT04827238
- Testing
- Standardized Invasive Hemodynamics
- Where
- 9 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- University of British Columbia
Aortic Stenosis
Reactive Oxygen Species Following Aortic Valve Replacement
Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for patients with severe symptomatic aortic stenosis (AS).
- Trial name
- ROS (NCT02841917)
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Infective Endocarditis
Characterization of RadiOlabeled Tracer Uptake Pattern in Noninfected Transcatheter Aortic Valves.
Therefore, the objective of the study is to characterize the pattern of radiolabeled tracer (18F-FDG) uptake in noninfected transcatheter heart valves in early follow-up after transcatheter aortic valve replacement (TAVR).
- Trial name
- COUNT (NCT03683355)
- Testing
- 18F-FDG PET/CT
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Aortic Valve Disease, Transcatheter Aortic Valve Implantation
The Sentinel Registry
This registry is to evaluate procedural outcomes and safety outcomes of cerebral protection devices during transfemoral TAVR in real-world clinical practice.
- Conditions
- Aortic Valve Disease, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
- Trial name
- Sentinel (NCT05217888)
- Testing
- Sentinel
- Where
- 10 sites in South Korea
- Volunteers
- 158 people
- Sponsor
- Duk-Woo Park, MD
Aortic Stenosis Symptomatic
Siegel™ Transcatheter Aortic Valve Replacement System (TAVR) Early Feasibility Study
The Siegel™ Transcatheter Aortic Valve (TAVR) early feasibility study objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic…
- Trial name
- NCT06680427
- Testing
- Siegel Transcatheter Aortic Valve (TAVR)
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- MiRus
Aortic Stenosis, Severe
Selection of Transcatheter Heart vaLve With Intermediate Sizing in Patients With Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Replacement
Transcatheter aortic valve implantation (TAVI) has evolved into a standard therapy for severe aortic stenosis across all surgical risk profiles, supported by pivotal trials in high- and low-risk populations.
- Trial name
- SELECT TAVR (NCT07689279)
- Testing
- Transcatheter Heart Valve
- Volunteers
- 604 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Tricuspid Valve Regurgitation, Heart Valve Diseases
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT06569602
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 23 sites in Germany, Greece and 4 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity…
- Trial name
- NCT06420830
- Testing
- SAPIEN 3 Ultra RESILIA Valve
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Aortic Stenosis, Symptomatic Aortic Stenosis
China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are…
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03314857
- Testing
- SAPIEN XT THV with the NovaFlex+ delivery system
- Where
- 3 sites in China
- Volunteers
- 67 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction
This study will be evaluate the autonomic, endothelial and hemodynamic functions, inspiratory muscle strength, peripheral tissue oxygenation, peripheral and respiratory muscle architecture, and inflammatory profile of severe AS…
- Trial name
- CARE-AS-MOTION (NCT02468219)
- Testing
- cardiovascular rehabilitation program
- Where
- Brazil
- Volunteers
- 120 people
- Sponsor
- Irmandade Santa Casa de Misericórdia de Porto Alegre
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard of care for aortic stenosis across all surgical risk categories, including low-risk, younger patients (≥70 years).
- Conditions
- Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening, Valve Expansion, Transcatheter Aortic Valve Replacement
- Trial name
- SYMMETRY (NCT07872020)
- Testing
- Double-TAP post-dilatation
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 422 people
- Sponsor
- Erasmus Medical Center
AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency
Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with TAVR without embolic protection (unprotected TAVR).
- Conditions
- AORTIC VALVE DISEASES, Aortic Valve Stenosis and/or Insufficiency, Aortic Valve Regurgitation, Aortic Valve Replacement
- Trial name
- EMBLOK II (NCT07129421)
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS")
- Volunteers
- 560 people
- Sponsor
- Emblok, Inc.
Aortic Valve Stenosis
Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement
Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older adults with severe symptomatic aortic stenosis who are considered high risk for surgical aortic valve replacement.
- Trial name
- REHAB-TAVR (NCT02805309)
- Testing
- Exercise, Cognitive behavioral interventions, Attention control education program
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Brigham and Women's Hospital
Frail Elderly, Exercise
The PERFORM-TAVR Trial
The PERFORM-TAVR trial (Protein and Exercise to Reverse Frailty in OldeR Men and women undergoing Transcatheter Aortic Valve Replacement) is a multicenter randomized clinical trial with a parallel-group design.
- Conditions
- Frail Elderly, Exercise, Dietary Supplements, Postoperative Care
- Trial name
- PERFORM-TAVR (NCT03522454)
- Testing
- Protein-rich oral nutritional supplement, Home-based supervised exercise program
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- Jewish General Hospital