Aortic Valve DiseaseUnilineNCT06025149
The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
An observational study of Aortic Valve Disease and Mitral Valve Disease, run by Closed Joint-Stock Company NeoCor at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Valve Disease, Mitral Valve Disease
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2018to 31 Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As part of these clinical trials (studies), the use of comparison groups is not planned.
Who may be able to join
- 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.
- Patient must be able to visit the Research Center.
Who cannot join
- 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.
- Patients with musculoskeletal conditions with severe movement disorders and diseases of the central nervous system, accompanied by cognitive disorders (disorientation, inability to independently reach the destination).
- Acute or subacute stages of infective endocarditis.
- Class IV heart failure according to the New York Heart Association Functional Classification with ongoing therapy, left ventricular ejection fraction less than 40%, myocardial infarction less than 90 days old, angina pectoris grade 4.
- The presence of severe somatic, neurological, mental and infectious diseases that worsen the prognosis of long-term survival: tuberculosis, human immunodeficiency virus, Alzheimer's disease, epilepsy, chronic kidney disease stage 3b (Glomerular Filtration Rate less than 30 mL/ min / 1.73 m²), chronic lung diseases requiring constant intake of corticosteroids and bronchodilators, multifocal atherosclerosis (grade 3 chronic lower limb ischemia, stenosis of the carotid arteries more than 50%, prior and planned interventions on the abdominal aorta, carotid arteries or arteries of the lower extremities).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Kemerovo, Kemerovo Oblast, 650002
Evgeny Bazdyrev, MD, PhD, +7-3842-64-42-40, clinicresearch@kemcardio.ru
Denis Lebedev, MD, +79138456592, mdlebedev@mail.ru
About this study
Official title: Open, Prospective, Multicenter Study of the Safety and Efficacy of "UniLine" Epoxy-treated Prosthesis Made From Xenopericardium in the Treatment of Isolated Aortic and Mitral Valve Diseases
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:
Read more
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.
Read the detailed description
Acquired heart diseases (AHDs) remain one of the most frequent causes of cardiac mortality and disability. In Russia, this kind of disease accounts for 7 to 25 % of all cardiovascular diseases, and is third most common cause of heart failure.
Heart valve replacement using a prosthetic heart valve remains the main and most effective method of treatment of AHDs. In Russia, AHDs are treated in more than 40 subjects by specialists from 92 medical institutions. Valve replacements, being high-tech methods of treatment, most effectively prolong the life of patients. Timely correction of AHD allows 75-95 % of patients to return to a normal lifestyle.
The aim of this study is to evaluate the safety and effectiveness of the "UniLine" epoxy-treated bioprosthesis in the treatment of isolated mitral or aortic heart valve diseases.
The expected clinical benefit involves the treatment of valvular disease with restoration of intracardiac hemodynamics during implantation of the "UniLine " bioprosthetic valve, followed by remodeling of the heart chambers, which should lead to an improvement in heart function and quality of life of the patient.
The expected risks are associated with taking anticoagulant therapy during the first three months after implantation, or as a result of prolonged anticoagulant therapy, in the presence of concomitant rhythm disturbances, and consist in the possibility of hemorrhagic or thromboembolic complications.
- Conditions
- Aortic Valve Disease, Mitral Valve Disease
- Keywords
- UniLine biological prosthesis, Acquired valve disease, Acquired aortic valve disease, Acquired mitral valve disease
- Medical subject headings
- Aortic Valve Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Fatal outcome: a) all-cause death; b) related to cardiovascular diseases; c) related to the dysfunction of the prosthesis.
- Life-threatening bleeding.
- Any dysfunction associated with the bioprosthesis (stenosis, regurgitation), migration of the device, thrombosis or other complication requiring surgical intervention.
- Any dysfunction associated with the bioprosthesis that does not require surgical intervention.
- Myocardial infarction (or stroke) or progression of a chronic form of ischemia requiring percutaneous coronary intervention or coronary artery bypass graft surgery
- Stroke
Measured: 12 years since the replacement surgery
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).
Measured: 12 years since the replacement surgery
Secondary 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).
Measured: 12 years since the replacement surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Sep 2018
- Primary completion9 Sep 2025 (estimated)
- Study completion31 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Closed Joint-Stock Company NeoCor
- Sponsor type
- University, hospital or other
- Collaborators
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia, CT Medical Limited Liability Company
- Responsible party
- Sponsor
- Investigators
- Alexander Bogachev-Prokofiev, MD, PhD, Principal investigator, National Medical Research Center named after Academician E.N. MeshalkinAlexey Evtushenko, MD, PhD, Principal investigator, Research Institute for Complex Issues of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025149
- Sponsor's protocol ID
- UniLine
- Acronym
- Uniline
- Status last verified
- Sep 2024
- First submitted
- 29 Aug 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Prospective, Multicenter Study of the Safety and Efficacy of "UniLine" Epoxy-treated Prosthesis Made From Xenopericardium in the Treatment of Isolated Aortic and Mitral Valve Diseases
- ClinicalTrials.gov ID
- NCT06025149
- Acronym / sponsor ID
- Uniline / UniLine
- Conditions
- Aortic Valve Disease, Mitral Valve Disease
- Keywords
- UniLine biological prosthesis, Acquired valve disease, Acquired aortic valve disease, Acquired mitral valve disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Closed Joint-Stock Company NeoCorUniversity, hospital or other
- Collaborators
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia, CT Medical Limited Liability Company
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 9 Sep 2025 (estimated)
- Study completion
- 31 Jan 2035 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acquired heart diseases (AHDs) remain one of the most frequent causes of cardiac mortality and disability. In Russia, this kind of disease accounts for 7 to 25 % of all cardiovascular diseases, and is third most common cause of heart failure.
Heart valve replacement using a prosthetic heart valve remains the main and most effective method of treatment of AHDs. In Russia, AHDs are treated in more than 40 subjects by specialists from 92 medical institutions. Valve replacements, being high-tech methods of treatment, most effectively prolong the life of patients. Timely correction of AHD allows 75-95 % of patients to return to a normal lifestyle.
The aim of this study is to evaluate the safety and effectiveness of the "UniLine" epoxy-treated bioprosthesis in the treatment of isolated mitral or aortic heart valve diseases.
The expected clinical benefit involves the treatment of valvular disease with restoration of intracardiac hemodynamics during implantation of the "UniLine " bioprosthetic valve, followed by remodeling of the heart chambers, which should lead to an improvement in heart function and quality of life of the patient.
The expected risks are associated with taking anticoagulant therapy during the first three months after implantation, or as a result of prolonged anticoagulant therapy, in the presence of concomitant rhythm disturbances, and consist in the possibility of hemorrhagic or thromboembolic complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As part of these clinical trials (studies), the use of comparison groups is not planned.
Key inclusion criteria (5 listed)
- 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.
- Patient must be able to visit the Research Center.
Key exclusion criteria (8 listed)
- 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.
- Patients with musculoskeletal conditions with severe movement disorders and diseases of the central nervous system, accompanied by cognitive disorders (disorientation, inability to independently reach the destination).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of the Bioprosthetic Valve
Time frame: 12 years since the replacement surgery
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
Long-Term Durability of the Bioprosthetic Valve
Time frame: 12 years since the replacement surgery
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).
1 secondary outcome
Hemodynamic characteristics of the Bioprosthetic Valve
Time frame: 12 years since the replacement surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
Related trials for Aortic Valve Disease
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Bogachev-Prokofiev, MD, PhD principal investigator
National Medical Research Center named after Academician E.N. Meshalkin
Alexey Evtushenko, MD, PhD principal investigator
Research Institute for Complex Issues of Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and Mitral Valve Disease, run by Closed Joint-Stock Company NeoCor at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Bazdyrev, MD, PhD (+7-3842-64-42-40, clinicresearch@kemcardio.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Bioprosthetic Valve (time frame: 12 years since the replacement surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.