Clinical trials: Transcatheter Aortic Valve Replacement
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
Severe Aortic Valve Stenosis
Validation of Accurate Commissural Alignment During Transcatheter Aortic Valve Implantation
Background: Transcatheter aortic valve replacement (TAVR) has become the preferred therapy for aortic stenosis. Given the growing life-expectancy, the risk of requiring coronary interventions or of developing prosthesis…
- Trial name
- ACA (NCT05097183)
- Testing
- Accurate Commissural Alignment (ACA)
- Where
- 15 sites in Spain
- Volunteers
- 274 people
- Sponsor
- Ignacio J. Amat Santos
Aortic Stenosis, Atrial Fibrillation New Onset
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
The purpose of the Long term Evaluation of Cardiac Arrhythmias after Transcatheter Aortic Valve Implantation (LOCATE) Registry is to perform long-term ambulatory monitoring of patients with severe aortic stenosis who undergo…
- Conditions
- Aortic Stenosis, Atrial Fibrillation New Onset, Heart Block
- Trial name
- NCT06055751
- Testing
- TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
Heart Block, Aortic Stenosis
Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).
The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in…
- Conditions
- Heart Block, Aortic Stenosis, Bundle-Branch Block
- Trial name
- GLUCO-TAVR (NCT06076824)
- Testing
- Methylprednisolone
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Hospital General Universitario de Alicante
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
Aortic Valve Stenosis, Arrhythmia
Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement
The TAVR-ELECTRO Registry (Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement) is a single-center, observational cohort study designed to systematically evaluate the occurrence, temporal evolution, and…
- Trial name
- TAVR-ELECTRO (NCT07390513)
- Testing
- TAVR Aspirin and clopidogrel
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Severe Aortic Valve Stenosis, Anxiety
Virtual Reality Assisted Conscious Sedation During TAVI
Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications.
- Conditions
- Severe Aortic Valve Stenosis, Anxiety, Pain
- Trial name
- TAVI_VR (NCT04259723)
- Testing
- VR during TAVI
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
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.
Stroke, Aortic Valve Stenosis
Acute STROke Complicating TAVI - Management and Outcomes
Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life.
- Conditions
- Stroke, Aortic Valve Stenosis, Periprocedural Complication
- Trial name
- ASTRO-TAVI (NCT05241821)
- Testing
- Mechanical thrombectomy, Thrombolytic Agent
- Where
- Israel
- Volunteers
- 484 people
- Sponsor
- Rabin Medical Center
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)
The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- NCT02491255
- Testing
- Lotus Valve System
- Where
- 5 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Cognition Disorder
Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions
Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI.
- Trial name
- KogniTa (NCT05464472)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Helios University Hospital Wuppertal
HFpEF - Heart Failure With Preserved Ejection Fraction, TAVI(Transcatheter Aortic Valve Implantation)
Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure
This study is a multicenter, double-blind, randomized, placebo-controlled trial. The purpose is to evaluate whether treatment with finerenone in patients with symptomatic severe aortic stenosis undergoing TAVI, and heart failure…
- Conditions
- HFpEF - Heart Failure With Preserved Ejection Fraction, TAVI(Transcatheter Aortic Valve Implantation), Finerenone
- Trial name
- FINE-VALUE (NCT07575672)
- Testing
- Finerenone
- Where
- 61 sites in China
- Volunteers
- 2,832 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Aortic Stenosis
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical…
- Trial name
- NCT04744857
- Testing
- The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Transcatheter Aortic Valve Replacement
Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)
Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)-guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose…
- Trial name
- NCT05637983
- Testing
- US-guided femoral puncture vs Fluoroscopy-guided puncture
- Where
- Italy
- Volunteers
- 508 people
- Sponsor
- Fondazione Toscana Gabriele Monasterio
Aortic Valve Stenosis
Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve
There is limited experience for the balloon expandable THV (transcatheter heart valve) on the need for predilation (ballon aortic valvuloplasty, BAV).
- Trial name
- EASE-IT (NCT02127580)
- Testing
- BAV, without BAV
- Where
- 7 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Stenosis
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR).
- Trial name
- CCQ (NCT01852552)
- Testing
- transcatheter aortic valve implantation, Aortic Valve Replacement
- Where
- Italy
- Volunteers
- 518 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Aortic Valve Regurgitation
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation
The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation.
- Trial name
- NCT06381271
- Testing
- Transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Xijing Hospital
Bicuspid Aortic Valve Disease
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVERS (NCT07413965)
- Testing
- Transcatheter Aortic Valve Replacement, the open chest surgery to replace the aortic valve
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Cedars-Sinai Medical Center