Clinical trials: Valve Replacement
Aortic Valve Stenosis
REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System
The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) in…
- Trial name
- REPRISE EDGE (NCT02854319)
- Testing
- LOTUS Edge Valve System
- Where
- 3 sites in Denmark, France and 1 more
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Replacement
PERCEVAL Pivotal Trial
The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community.
- Trial name
- NCT00860730
- Testing
- Aortic valve replacement with Perceval aortic heart valve
- Where
- 9 sites in Belgium, France and 2 more
- Volunteers
- 150 people
- Sponsor
- Corcym S.r.l
Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation
Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis and Mitral Regurgitation
The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
- Trial name
- TIAMAR (NCT05310461)
- Testing
- Transcatheter or surgical aortic valve replacement with or without transcatheter or surgical mitral valve repair/replacement, Deferred treatment, with intervention once AVA is ≤1.0 cm2 or if concomitant mitral regurgitation meets an indication for intervention
- Where
- 3 sites in Switzerland
- Volunteers
- 80 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Stenosis, Left Ventricular Hypertrophy
Effect of Angiotensin II Receptor Blockers (ARB) on Left Ventricular Reverse Remodelling After Aortic Valve Replacement in Severe Valvular Aortic Stenosis
The consequence of aortic valve stenosis (AVS) is increased pressure load on the left ventricle which causes left ventricular (LV) hypertrophy, and myocardial stretch will cause activation of cardiac peptides and activation of…
- Conditions
- Aortic Valve Stenosis, Left Ventricular Hypertrophy, Atrial Fibrillation
- Trial name
- NCT00294775
- Testing
- Candesartan
- Where
- Denmark
- Volunteers
- 140 people
- Sponsor
- Odense University Hospital
Transcatheter Aortic Valve Replacemen, Echocardiography
Echocardiography Guided TAVR (Echo TAVR)
Conventional transcatheter aortic valve replacement (TAVR) relies on fluoroscopic and contrast agents. However, in high-risk patients, exposure to ionizing radiation and contrast agents is contraindicated and undesirable.
- Trial name
- NCT07030062
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Pan Xiangbin
Aortic Valve Stenosis
DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR
Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
- Trial name
- NCT02073851
- Testing
- TriGuard™HDH
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Keystone Heart
Bicuspid Aortic Valve, Aortic Valve Stenosis
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients…
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases
- Trial name
- ARDITAV (NCT05708118)
- Testing
- Echocardiographic assessment., Computed-tomography assessment
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Percutaneous Coronary Intervention, Valve Repair/Replacement
Cardiac Rehab Referral Nudges
Investigators will evaluate the effectiveness of two different EHR-embedded nudges to improve referral to cardiac rehabilitation.
- Conditions
- Percutaneous Coronary Intervention, Valve Repair/Replacement, Coronary Artery Bypass Grafting
- Trial name
- NCT07607522
- Testing
- EHR Nudges
- Where
- United States
- Volunteers
- 7,000 people
- Sponsor
- NYU Langone Health
Inflammasomes, Cognitive Dysfunction
Correlation of NLRP3 With Cognitive Dysfunction Early After Heart Valve Replacement Surgery
The investigators decided to assess the prognostic value of NLRP3 inflammasome level in early after heart valve replacement surgery and whether it was related to postoperative cognitive dysfunction.
- Conditions
- Inflammasomes, Cognitive Dysfunction, Pyrin Domain-Containing 3 Protein, Postoperative Complications
- Trial name
- NCT04191642
- Where
- China
- Volunteers
- 75 people
- Sponsor
- General Hospital of Ningxia Medical University
Aortic Valve Stenosis
Vascular Closure Device in Transcatheter Aortic Valve Replacement
Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a…
- Trial name
- NCT04392492
- Testing
- MANTA vascular closure device
- Where
- Sweden
- Volunteers
- 1,000 people
- Sponsor
- Karolinska University Hospital
Bicuspid Aortic Valve, Ascending Aorta Aneurysm
Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement
Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications.
- Trial name
- NCT05836363
- Testing
- Ascending aorta replacement
- Where
- Italy
- Volunteers
- 75 people
- Sponsor
- Michele De Bonis
Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities
- Trial name
- NCT02987387
- Testing
- SAPIEN XT THV
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Edwards Lifesciences
Ascending Aortic Aneurism, Aortic Valve Insufficiency
Study of Aortic Root Reimplantation Procedure
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.
- Trial name
- STAR (NCT01787604)
- Testing
- Aortic Root Reimplantation Procedure, Aortic Valve Reimplantation Procedure
- Where
- Russia
- Volunteers
- 64 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Diseases of Aortic Valve, Aortic Stenosis Disease
Clinical Trial in China for Aortic Valve Stenosis
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.
- Trial name
- NCT05607667
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in China
- Volunteers
- 15 people
- Sponsor
- Genesis Medtech Corporation
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
Pathological Processes, Cardiomyopathies
Adenosine as an Adjunct to Blood Cardioplegia
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction.
- Trial name
- NCT02681913
- Testing
- Adenosine
- Where
- Netherlands
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Amphia Hospital
Mitral Valve Insufficiency, Heart Failure
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the…
- Trial name
- SMMART-HF (NCT00608140)
- Testing
- Surgical mitral valvuloplasty with placement of annular ring (SMVR), Optimal medical therapy (OMT)
- Where
- 9 sites in United States, Canada
- Volunteers
- 2 people
- Sponsor
- Duke University
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
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