Tests the Venus-Neo surgical aortic valve in people needing valve replacement
Tests a new heart valve device in adults who need aortic valve replacement.
Plain-language title generated from the registry record
Registry title: A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
Key facts
- Where
- Berlin, GermanySee the site
Where in Germany
- Deutsches Herzzentrum Berlin-CharitéBerlin, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jilin Venus Haoyue Medtech Limited
- Trial code
- NCT05941455
- Record updated
- 12 July 2023
- Original description
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.Read full original descriptionShow less
A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
Inclusion: Age ≥ 18 years; Patients who are clinically indicated for aortic valve replacement; Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent.
Exclusion: Previous surgical or/and transcatheter cardiac valve replacement at any site; Previous open-heart surgical valve repair at any site; Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days; Acute myocardial infarct within the previous 30 days; Previous organ transplant or currently an organ transplant candidate Anatomical; Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement; Planned relevant concomitant procedure within 30 days post index procedure; Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial; Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention; Untreated clinically significant coronary artery diseases requiring revascularization; Severe right heart dysfunction; Active infection requiring antibiotic therapy including infective endocarditis; Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability; Severe chronic lung disease; Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance; Life expectancy ≤ 1 year due to non-cardiac reasons; Chronic kidney disease (eGFR<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis; Hematologic disorders: Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), thrombocytopenia (Plt< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Hematooncology specialists; LVEF < 20%; Hypertrophic obstructive cardiomyopathy (HOCM); Severe symptomatic carotid artery stenosis; Left ventricular end diastolic diameter (LVEDD) >70mm; Echocardiographic evidence of intracardiac mass, thrombus, or vegetation; Native aortic valve geometry and size unfavorable for study bioprosthetic valve General; Urgent, emergency or salvage surgeries; Pregnant, breastfeeding or intend to become pregnant within 1 year; Currently incarcerated or unable to give voluntary informed consent.