Clinical trials: Valve
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
Aortic Valve Stenosis, Artifical Intelligence
Smartphone Based Digital Screening for Aortic Valve Stenosis
Heart valve diseases are among the most serious cardiovascular conditions in older age. One of the most common forms is aortic valve stenosis, a narrowing of the valve opening between the left ventricle and the main artery.
- Trial name
- SMART-VALVE (NCT07284550)
- Testing
- Smartphone-based signal acquisition
- Where
- Austria
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck
Aortic Valve Replacement, Antithrombotic Therapy
Apixaban for the Prevention of Latent Biological Valve Thrombosis
Background: The optimal antithrombotic strategy early after aortic valve replacement surgery with a biological valve remains controversial due to lack of high-quality evidence.
- Conditions
- Aortic Valve Replacement, Antithrombotic Therapy, Bioprosthetic Valve Thrombosis, Rapid Deployment Valves
- Trial name
- NCT06184113
- Testing
- Aortic valve replacement surgery, Computed tomography, Echocardiography
- Where
- Croatia
- Volunteers
- 166 people
- Sponsor
- Clinical Hospital Centre Zagreb
Heart Block, Valve Heart Disease
Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter
This is a prospective, single-center, non-randomized open label study. The objective of this study is to evaluate the efficacy and safety of the Sync-AV II Temporary Cardiac Pacing Catheter in subjects whose elective surgical or…
- Trial name
- NCT06261788
- Testing
- Temporary pacing
- Where
- Paraguay
- Volunteers
- 30 people
- Sponsor
- Swift Sync, Inc.
Rheumatic Disease of Heart Valve, Ischemic Reperfusion Injury
Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace
The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.
- Trial name
- NCT01476969
- Testing
- Remote ischemic postconditioning
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Central South University
Aortic Valve Stenosis
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.
- Trial name
- LOTUS-CHINA (NCT02536703)
- Testing
- Lotus Valve System
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Heart Failure, Valvular Heart Disease
Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions (PLUTO-II)
The aim of PLUTO-II is to use biventricular pressure-volume (PV) loop measurements to improve the understanding of direct changes in cardiac and hemodynamic physiology induced by transcatheter aortic valve implantation (TAVI) or…
- Conditions
- Heart Failure, Valvular Heart Disease, Aortic Stenosis, Mitral Insufficiency
- Trial name
- PLUTO-II (NCT06204783)
- Testing
- Pressure volume (PV) loop measurement
- Where
- Netherlands
- Volunteers
- 157 people
- Sponsor
- Erasmus Medical Center
Aortic Valve Stenosis
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
- Trial name
- NCT04665596
- Testing
- Ultrasound treatment
- Where
- Serbia
- Volunteers
- 10 people
- Sponsor
- Cardiawave SA
Coronary Artery Disease, Aortic Valve Stenosis
Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation
The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.
- Conditions
- Coronary Artery Disease, Aortic Valve Stenosis, TAVI, PCI
- Trial name
- NOTION-3 (NCT03058627)
- Testing
- PCI
- Where
- 12 sites in Denmark, Finland and 2 more
- Volunteers
- 454 people
- Sponsor
- Thomas Engstrom
Mechanical Prosthetic Heart Valve Implantation, Patient Self Monitoring of Oral Anticoagulent Therapy
Benefit of Self-monitoring of Anticoagulation Instrument
To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.
- Trial name
- 4A (NCT00506870)
- Testing
- INRatio / Coaguchek XS
- Where
- France
- Volunteers
- 919 people
- Sponsor
- University Hospital, Bordeaux
Aortic Stenosis
PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis
Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world.
- Trial name
- PROVE (NCT05539573)
- Testing
- Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.
- Where
- 27 sites in France, Germany and 2 more
- Volunteers
- 1,043 people
- Sponsor
- University of Leipzig
Cardiac Valves, Heart Valve Diseases
Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.
- Conditions
- Cardiac Valves, Heart Valve Diseases, Valvular Insufficiency
- Trial name
- PVL closure (NCT03793296)
- Testing
- Percutaneous Device Closure: Vascular plug
- Where
- South Korea
- Sponsor
- Seung-Jung Park
Hydrocephalus, Normal Pressure Hydrocephalus
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
The purpose of this study is to determine the agreement rate between the CODMAN Valve Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in order to support an alternative to X-ray confirmation…
- Trial name
- NCT00196196
- Testing
- Codman VPV System
- Where
- 8 sites in United States
- Volunteers
- 274 people
- Sponsor
- Codman & Shurtleff
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Performance Study of the Harpoon Mitral Valve Repair System
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT03285724
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 2 sites in Poland
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
Congenital Heart Defects, Heart Valve Diseases
Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)
Conventional cardiac operations are performed with median sternotomy, which is related to great wound, morbidities, longer duration in hospital and most significantly, cosmetic problems.
- Trial name
- CPB (NCT00921596)
- Testing
- cardiac operation with totally endoscopic method
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Xijing Hospital
Aortic Valve Stenosis, Extracorporeal Circulation
Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound
In this study, the investigators aim to compare cerebral embolic load in patients undergoing surgical aortic valve replacement using either the minimized extracorporeal circulation or the conventional extracorporeal circulation…
- Trial name
- AKE-MECC (NCT02308566)
- Testing
- Minimized Extracorporeal Circulation (MECC), Conventional Extracorporeal Circulation (CECC)
- Where
- Switzerland
- Volunteers
- 48 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Stenosis, Coronary Artery Disease
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention…
- Conditions
- Aortic Stenosis, Coronary Artery Disease, TAVI, PCI
- Trial name
- TAVI-PCI (NCT04310046)
- Testing
- PCI before TAVI, PCI after TAVI
- Where
- 48 sites in Austria, France and 4 more
- Volunteers
- 986 people
- Sponsor
- University of Zurich
Aortic Stenosis
ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been…
- Trial name
- NCT07827105
- Testing
- AK-AVS
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- AccurKardia, Inc.
Haemoptysis
Endobronchial Valves in Inoperable Patients With Haemoptysis
Massive haemoptysis is a life-threatening condition which is commonly seen in patients who have previously had pulmonary tuberculosis.
- Trial name
- NCT02816229
- Testing
- Insertion of endobronchial valve
- Volunteers
- 20 people
- Sponsor
- University of Stellenbosch
Chronic Pain, Intractable Pain
Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS)
Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).
- Conditions
- Chronic Pain, Intractable Pain, Back Pain
- Trial name
- TRANSIT (NCT03876158)
- Testing
- Prometra II Programmable Pump system(Flowonix Medical)
- Where
- United States
- Sponsor
- Rush University Medical Center
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