Clinical trials: Heart Valve Prosthesis Implantation
Valvular Endocarditis
Surgical Management of Valvular Endocarditis
This study aims to achieve the following objectives objective 1 : To review the Investigators' experience of surgical management of infective endocarditis (IE) and analyze the outcomes and associated prognostic factors objective…
- Trial name
- NCT04572529
- Testing
- Cardiac Valve replacement
- Volunteers
- 50 people
- Sponsor
- Assiut University
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
Eisenmenger Syndrome
Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves
A growing body of data, suggests that transcatheter valves are effective when implanted in other locations (mitral, aortic, tricuspid) and in high pressure environments.
- Trial name
- NCT02119442
- Testing
- Transcather Valve Implantation
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- University of California, Los Angeles
Aortic Valve Insufficiency
Results of the Aortic Valve Reconstruction in Children
Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system.
- Trial name
- NCT04162444
- Testing
- Physical examination, The Ross Classification for Heart Failure in Children, The Aristotle score
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- National Medical Research Center for Children's Health, Russian Federation
Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis
Supra-Annular vs. Annular ValvEs for Small Annuli
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
- Trial name
- SAVE (NCT04372381)
- Testing
- Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Where
- 3 sites in United States
- Sponsor
- University of Arizona
Aortic Valve Disease
REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation
There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day…
- Trial name
- REBOOT (NCT02668484)
- Testing
- repositionable valve prosthesis, balloon-expandable valve prosthesis
- Where
- 3 sites in Germany, Italy
- Volunteers
- 116 people
- Sponsor
- LMU Klinikum
Kidney Failure, Chronic, Coronary Artery Disease
Prophylactic Effect of Nifedipine on Further Decline in Renal Function in Patients Undergoing Open-Heart Surgery
To compare renal function (51Cr-EDTA clearance) 48 hours post open-heart surgery (coronary bypass or valve surgery) in patients with impaired renal function after randomization to either nifedipine infusion at start of surgery…
- Trial name
- NCT00244530
- Testing
- Nifedipine
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- University of Oslo School of Pharmacy
Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation
TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries. The main questions it aims to answer are: 1.
- Conditions
- Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Commissural Alignment, Commissural Misalignment
- Trial name
- NCT06896227
- Testing
- transthoracic echocardiography
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
AORTIC VALVE DISEASES, Aortic Stenosis
Invasive Versus Echocardiography-derived Transvalvular Gradients After TAVI Usign Balloon-expandable Transcatheter Heart Valves.
The aim of this prospective registry is to compare invasive versus echocardiography-derived transvalvular gradients before and after TAVI with balloon-expandable THVs.All patients will undergo a transthoracic echocardiogram in…
- Trial name
- IVEGA-TAVI (NCT06753227)
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Cardiac Anaesthesia
Registry of Cardio/Neurovascular Anesthesia Including the Database of Biological Signals During Anesthesia, Preoperative Assessment and Prognosis in Patients
The purpose of this study is to establish a registry database for patients undergoing anesthesia for cardiovascular surgery or procedures in our operating or hybrid room. The following information will be collected: 1.
- Trial name
- NCT04833751
- Where
- South Korea
- Volunteers
- 10,000 people
- Sponsor
- Yonsei University
Aortic Valve Stenosis
TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3
Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- DIRECTAVI (NCT02729519)
- Testing
- TAVI
- Where
- France
- Volunteers
- 250 people
- Sponsor
- University Hospital, Montpellier
Valve Heart Disease, Coronary Artery Disease
Post-Operative Myocardial Incident & Atrial Fibrillation
To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with…
- Trial name
- POMI-AF (NCT03376165)
- Where
- France
- Volunteers
- 1,500 people
- Sponsor
- University Hospital, Lille
Aortic Valve Stenosis, Valsartan
Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study
Aortic stenosis (AS) is the most frequent valvular heart disease in Western countries, with increasing prevalence. Recent guidelines recommend aortic valve intervention (surgical aortic valve replacement [SAVR] or transcatheter…
- Conditions
- Aortic Valve Stenosis, Valsartan, Angiotensin Receptor Antagonists, Transcatheter Aortic Valve Replacement
- Trial name
- ARISTOTE (NCT03315832)
- Testing
- Valsartan
- Where
- France
- Sponsor
- University Hospital, Limoges
Structural Valve Deterioration, Structural Valve Degeneration
The ReTAVI Prospective Observational Registry
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a…
- Conditions
- Structural Valve Deterioration, Structural Valve Degeneration, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction
- Trial name
- NCT05601453
- Testing
- Elective redo transcatheter aortic valve implantation (redo-TAVI)
- Where
- 62 sites in Austria, Canada and 9 more
- Volunteers
- 250 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Cardiac Surgery, Peri Operative Medicine
Risk Factors of Atrial Fibrillation After Cardiac Surgery
Supraventricular arrhythmias complicate more than 40% of cardiac surgeries and are associated with an increased risk of bleeding, stroke, heart failure, and death.
- Conditions
- Cardiac Surgery, Peri Operative Medicine, Thoracic Surgery, Cardiopulmonary Bypass
- Trial name
- PFAS (NCT07625033)
- Where
- France
- Volunteers
- 918 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
REVIVE-FR Registry
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly.
- Conditions
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis
- Trial name
- NCT07885761
- Testing
- TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation of a Failed Transcatheter Heart Valve
- Volunteers
- 200 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Hydra Registry - Italy Experience
Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.
- Trial name
- NCT05956652
- Testing
- Hydra Transcatheter Aortic Valve System
- Where
- 4 sites in Italy
- Sponsor
- Sahajanand Medical Technologies Limited
Atrial Fibrillation, Thrombus Due to Heart Valve Prosthesis
Validation of International Warfarin Pharmacogenetics Consortium (IWPC) Algorithm in Elderly Patients With Comorbidity
The purpose of this study is to validate the International Warfarin Pharmacogenetics Consortium (IWPC) algorithm in a prospective cohort of elderly people (65 years or older) with heart valves and/or nonvalvular atrial…
- Trial name
- VIALE (NCT02069132)
- Testing
- Warfarin
- Where
- 3 sites in Italy
- Volunteers
- 376 people
- Sponsor
- University of Campania Luigi Vanvitelli