The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorClosed Joint-Stock Company NeoCor
About this trial
The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic/mitral valve replacement using the "UniLine" bioprosthesis in patients with acquired aortic or mitral valve diseases.
Main research objectives:
To analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the "UniLine" bioprosthesis.
To study the hemodynamic characteristics of normally functioning "UniLine " prostheses in the mitral or aortic valve position based on the transthoracic echocardiography data.
To assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the results of their treatment.
To analyze the frequency of major serious adverse events associated with the "UniLine" bioprosthesis or procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provided informed consent to participate in the study.
Must be aged 18 years and older.
Patients with isolated acquired mitral or aortic valve disease.
No prior heart valve replacement, current replacement must be planned (not conducted in an urgent/ emergency manner), using the "UniLine" biological prosthesis made from xenopericardium.
Disqualifiers
Mechanical or biological prosthesis in another position. Patients with tricuspid valve repair may be included in the study.
Prior heart valve replacement.
Concomitant interventions on the heart (coronary artery bypass grafting, coronary heart disease treatment, surgical reconstruction of a left ventricular aneurysm) and thoracic aorta.
Patients with cancer in history.
Trial population
As part of these clinical trials (studies), the use of comparison groups is not planned.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Safety of the Bioprosthetic Valve
Safety of using the bioprosthesis is defined as the absence of major adverse events related to the device or procedure, assessed using the following clinical phenomena: 1. Fatal outcome: a) all-cause death; b) related to cardiovascular diseases; c) related to the dysfunction of the prosthesis. 2. Life-threatening bleeding. 3. Any dysfunction associated with the bioprosthesis (stenosis, regurgitation), migration of the device, thrombosis or other complication requiring surgical intervention. 4. Any dysfunction associated with the bioprosthesis that does not require surgical intervention. 5. Myocardial infarction (or stroke) or progression of a chronic form of ischemia requiring percutaneous coronary intervention or coronary artery bypass graft surgery 6. Stroke
Time frame
12 years since the replacement surgery2
Long-Term Durability of the Bioprosthetic Valve
It will be evaluated by measuring the hemodynamic characteristics of the prosthetic valve, assessed by echocardiography: maximum, average gradients and effective orifice area (absolute and indexed values).
Time frame
12 years since the replacement surgerySecondary outcomes
1
Hemodynamic characteristics of the Bioprosthetic Valve
They will be assessed by using echocardiography: maximum, average gradients and effective orifice area (absolute and indexed values).
Time frame
12 years since the replacement surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Closed Joint-Stock Company NeoCor
Lead sponsor
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Collaborator
CT Medical Limited Liability Company
Collaborator
Source ClinicalTrials.gov