Clinical trials: Heart Valve Prosthesis Implantation
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
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
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
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
Aortic Valve Stenosis, Aortic Valve Calcification
Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis
1. objectives Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Trial name
- Venus-A (NCT01683474)
- Testing
- Venus MedTech Aortic Valve Prosthesis
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Aortic Valve Disease
Transapical Implantation of Ventor Embracer™ Valve in Patients With Severe Aortic Valve Disease
A prospective single arm study evaluating feasibility and safety of a catheter-based transapical implantation of the Ventor Embracer™ aortic valve bioprosthesis in patients with severe aortic valve disease, specifically aortic…
- Trial name
- NCT00677638
- Testing
- Ventor Embracer
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Ventor Technologies
Aortic Valve Stenosis
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system.
- Trial name
- NCT01051518
- Testing
- Medtronic CoreValve System
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
AORTIC VALVE DISEASES, Mitral Valve Disease
Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve
The goal of this clinical trial is to explore the early feasibility, initial safety, and efficacy of surgical implantation of a polymer prosthetic heart valve in patients requiring either mitral valve replacement or aortic valve…
- Conditions
- AORTIC VALVE DISEASES, Mitral Valve Disease, Aortic Stenosis, Aortic Regurgitation
- Trial name
- POLYVALVE-FIH (NCT07097740)
- Testing
- Polymer Prosthetic Heart Valve
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Mitrassist Lifesciences Limited Co., Ltd.