Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-70
SponsorClosed Joint-Stock Company NeoCor
About this trial
The goal of this multicenter prospective cohort study is to evaluate the long-term safety and efficacy of clinical outcomes of aortic valve replacement using the "TiAra" prosthesis with or without concomitant procedures.
Main research objectives:
1. To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the "TiAra" prosthesis. 2. To study the hemodynamic characteristics of normally functioning "TiAra" prostheses in the aortic position, as well as the condition of the heart chambers in short and long-term period (up to 10 years) after the implantation. 3. To assess complications of the early and mid-term follow-up periods of aortic valve replacement using the "TiAra" prosthesis.
This study does not presuppose implementation of comparison groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient's written consent to participate in the study and the absence of restrictions on physical movement (diseases of the musculoskeletal system and diseases of the central nervous system, accompanied by cognitive disorders (disorientation, inability to independently reach the destination).
The patient is a resident of the city* (suburb) where the institution is conducting study.
Age: 60-70 years old with a life expectancy of 3 years or more. Or a person younger than 60 with contraindications to taking anticoagulants, or with increased risk of their use, consciously choosing a biological prosthesis for valve replacement.
Isolated aortic valve disease.
Disqualifiers
The presence of severe somatic, neurological, mental diseases and infectious diseases that worsen the prognosis of long-term survival (ischemic heart disease, tuberculosis, human immunodeficiency viruses, Alzheimer's disease, epilepsy, insulin-requiring diabetes, kidney disease with creatinine clearance less than 85 mL/min, chronic lung disease requiring chronic corticosteroids and bronchodilators, multifocal atherosclerosis (intermittent claudication, carotid arteries stenosis of more than 50%, prior and planned interventions on abdominal area, carotid arteries or arteries of the lower extremities).
The patient has any not related to the underlying cardiovascular system disease pathology that will lead to the death of the patient in less than 1 year.
The patient is currently participating in a study of a new drug or other medical devices.
Trial population
As part of these clinical trials (studies), the use of comparison groups is not planned.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
1. Incidence of Treatment-Emergent Adverse Events, requiring repeated surgical intervention in the long term (long-term safety and durability)
Long-term safety of the "TiAra" epoxy-treated prosthesis made with xenopericardium will be evaluated by the frequency of complications associated with the valve. Device safety is defined as the absence of severe adverse events associated with the device or procedure, assessed by the following clinical phenomena: Death Severe complications of the heart Life-threatening bleeding Any bioprosthesis-related dysfunction, migration, thrombosis or other complication requiring an open-heart surgery or repeated intervention. Myocardial infarction or progression of a chronic form of ischemia requiring percutaneous coronary intervention and coronary artery bypass grafting Access site complications Stroke
Time frame
Up to 12 years from the moment of implantation .2
2. Incidence of Treatment-Emergent Adverse Events, requiring repeated surgical intervention in the short term (short-term safety)
Short-term safety of the "TiAra" epoxy-treated prosthesis made with xenopericardium in the treatment of isolated mitral and aortic valve diseases will be evaluated by the frequency of complications associated with the valve. Device safety is defined as the absence of severe adverse events associated with the device or procedure, assessed by the following clinical phenomena: hemolysis hemolytic anemia a heart stroke myocardial infarction hemorrhaging and bleeding heart arrhythmia nonstructural dysfunction pannus prosthesis-patient mismatch dislocation paraprosthetic and transprosthetic regurgitation heart failure breast-pang structural deterioration valve thrombosis thromboembolism encarditis a reoperation
Time frame
Up to 12 years from the moment of implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Closed Joint-Stock Company NeoCor
Lead sponsor
CT Medical Limited Liability Company
Collaborator
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Collaborator
Source ClinicalTrials.gov