Clinical trials: Transcatheter Aortic Valve Replacement (TAVR)
Aortic Valve Stenosis
A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device
A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI)…
- Trial name
- NCT01721642
- Testing
- Apica Cardiovascular ASC Access, Stability and Closure Device
- Volunteers
- 31 people
- Sponsor
- Apica Cardiovascular Limited
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 Valve Stenosis
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement…
- Trial name
- RADIANT CE (NCT03805711)
- Testing
- HLT® Transcatheter System
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- HLT Inc.
Severe Symptomatic Aortic Stenosis
Alternative Access Approaches for Transcatheter Aortic Valve Replace (TAVR) in Inoperable Patients With Aortic Stenosis
Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have…
- Trial name
- Inop AA (NCT01787084)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve
- Volunteers
- 8 people
- Sponsor
- The Society of Thoracic Surgeons
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
Aortic Regurgitation
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.
- Trial name
- RIVAL - AR EFS (NCT05409378)
- Testing
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Where
- 3 sites in United States
- Sponsor
- HLT Inc.
Aortic Valve Stenosis
The preDIlatation in tRanscathEter aortiC Valve implanTation Trial
This is a randomized trial that will evaluate the role of balloon aortic valvuloplasty (BAV) on the outcome of patients undergoing transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- DIRECT (NCT02448927)
- Testing
- balloon aortic valvuloplasty, Transcatheter Aortic Valve Implantation
- Where
- 4 sites in Greece, Israel
- Volunteers
- 170 people
- Sponsor
- National and Kapodistrian University of Athens
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 Valve Stenosis
Anticoagulant Versus Dual Antiplatelet Therapy for Preventing Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement
This trial is to compare the efficacy of NOAC(Novel Oral Anticoagulants) with edoxaban vs. dual antiplatelet therapy (DAPT) for prevention of leaflet thrombosis (documented by cardiac CT imaging) and cerebral embolization…
- Trial name
- ADAPT-TAVR (NCT03284827)
- Testing
- NOAC, DAPT
- Where
- 5 sites in Hong Kong, South Korea and 1 more
- Volunteers
- 235 people
- Sponsor
- Duk-Woo Park, MD
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
Aortic Stenosis, Cerebral Ischaemic Injury
Perioperative Intensive Statin Therapy for Neuroprotection in TAVR（PISTNT）
Transcatheter aortic valve replacement (TAVR) has become the most anticipated treatment method in the cardiovascular field in recent years, experiencing rapid development.
- Trial name
- PISTNT (NCT07087379)
- Testing
- Intensive statin treatment
- Volunteers
- 500 people
- Sponsor
- Pan Xiangbin
Aortic Valve Stenosis, Cardiac Amyloidosis
Targeted Testing for ATTR Among Aortic Stenosis Patients-Pilot
Our ultimate goal is to design a multi-center randomized trial to test the hypothesis that targeted testing for transthyretin cardiac amyloid (ATTR) will improve survival and health status among aortic stenosis patients who…
- Trial name
- NCT04363294
- Testing
- PYP scan
- Sponsor
- University of Texas Southwestern Medical Center
Valve Stenoses, Aortic
Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?
Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS).
- Trial name
- SAFER-TAVI (NCT06284837)
- Testing
- Access site
- Where
- 3 sites in Australia
- Volunteers
- 542 people
- Sponsor
- The Alfred
Severe Symptomatic Aortic Stenosis
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
- Trial name
- Portico TA EU (NCT01742598)
- Testing
- Portico Transapical Aortic Valve System
- Where
- United Kingdom
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis
Aspirin vs Clopidogrel After TAVR
Currently, the optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains still unknown., The purpose of the study is to compare aspirin versus clopidogrel monoantiplatelet therapy for preventive…
- Trial name
- NCT05493657
- Testing
- Aspirin single antiplatelet therapy, Clopidogrel single antiplatelet therapy
- Where
- South Korea
- Volunteers
- 270 people
- Sponsor
- Yonsei University
TAVI(Transcatheter Aortic Valve Implantation)
Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
The TAVIPILOT Software by Caranx Medical is an advanced intraoperative assistance tool designed to enhance the accuracy of transcatheter aortic valve positioning during TAVI.
- Trial name
- SAITO 1B (NCT07100340)
- Testing
- TAVR using a guidance software
- Volunteers
- 10 people
- Sponsor
- Caranx Medical
Stroke, Transcatheter Aortic Valve Replacement (TAVR)
A Clinical Study on the Use of the Sentinel Cerebral Protection Device During TAVR for the Prevention of Procedure-Related Stroke
After more than a decade of development, transcatheter aortic valve replacement (TAVR) is now a standard, guideline-recommended treatment for all symptomatic patients with severe aortic stenosis, regardless of their surgical…
- Conditions
- Stroke, Transcatheter Aortic Valve Replacement (TAVR), Aortic Stenosis Treated With TAVI
- Trial name
- SENTINEL-TAVR (NCT07045233)
- Testing
- Sentinel® Cerebral Protection System, MRI
- Where
- China
- Volunteers
- 200 people
- Sponsor
- China National Center for Cardiovascular Diseases
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, Severe
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT04944667
- Testing
- TAVR planning
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Centro Medico Teknon
Aortic Regurgitation, Transcatheter Aortic Valve Replacement (TAVR)
TAVR for Aortic Regurgitation Under TTE Guidance
Transcatheter aortic valve replacement (TAVR) is an established therapy for severe aortic valve disease, yet conventional workflows rely on fluoroscopy and iodinated contrast, exposing patients and operators to ionizing radiation…
- Trial name
- NCT07458672
- Testing
- TTE guided TAVR
- Volunteers
- 30 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital