Aortic Valve DiseaseTiAraNCT05998694
Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
An observational study of Aortic Valve Disease and Artificial Heart Valves, run by Closed Joint-Stock Company NeoCor at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Aortic Valve Disease, Artificial Heart Valves
- How many people
- 2,000 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2021to 10 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 to 70 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
- 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.
- - participation is also possible for those living in the rural areas, but they have to be able to make visits to the Research Center.
- 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.
- Real intervention on the heart valve is primary.
Show all 11Show fewer
- Absence of concomitant interventions on the heart and thoracic aorta**.
- - Coronary artery bypass grafting, correction of tricuspid valve disease, previously treated congenital heart defects, aortic intervention
- The intervention on the valve is planned (that is, it is not carried out in expedited/urgent manner or is not a "rescue" operation).
- Absence of acute and subacute infective endocarditis.
- The following factors should not be present before surgery: high pulmonary hypertension (pulmonary arterial systolic pressure more than 60 mmHg), functional class 4 (according to the New York Heart Association Functional Classification) while in ongoing treatment, left ventricular ejection fraction less than 30%.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Kemerovo, Kemerovo Oblast, 650002
Alexey Evtushenko, MD, PhD, +7 (3842) 64-33-08, ave@kemcardio.ru
Denis Lebedev, MD, +79138456592, mdlebedev@mail.ru
About this study
Official title: Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis "ТiAra" (T-ara)
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:
Read more
- To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the "TiAra" prosthesis.
- 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.
- 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.
Read the detailed description
Cardiovascular system diseases are one of the main causes of death worldwide. Heart valve diseases are considered one of the most important issues associated with the cardiovascular system. The replacement of heart valves includes the production of prostheses that provide functional consistency with exceptionally high reliability and appropriate fatigue strength. The proposed new biological valve with a frame made of super-elastic material allows preserves the natural biomechanics of the reconstructed valve and has high biocompatibility and resistance to infection due to the use of biological material as a frame covering. The "TiAra" bioprosthetic valve has the ability to deform during the cardiac cycle in accordance with the deformations of the fibrous structures of the patients' aortic root. The implanted valve fully integrates into the native aortic root.
The purpose of these clinical trials is to obtain clinical data confirming the efficacy and safety of the bioprosthesis under normal conditions in humans.
The expected clinical benefit involves the treatment of valvular disease with restoration of intracardiac hemodynamics during implantation of the "TiAra" 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. In order to reduce the risks caused by anticoagulant therapy, it is planned to carry out measures aimed at restoring the sinus rhythm and ensuring proper control of the indicators of the blood coagulation system.
- Conditions
- Aortic Valve Disease, Artificial Heart Valves
- Keywords
- aortic valve, aortic valve bioprothesis TiAra, valve bioprosthesis, 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
- Medical subject headings
- Aortic Valve Disease, Hemolysis, Anemia, Hemolytic, Myocardial Infarction, Hemorrhage, Arrhythmias, Cardiac, Joint Dislocations, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 years from the moment of implantation .
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
Measured: Up to 12 years from the moment of implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jun 2021
- Primary completion10 Aug 2025 (estimated)
- Study completion10 Aug 2026 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Closed Joint-Stock Company NeoCor
- Sponsor type
- University, hospital or other
- Collaborators
- CT Medical Limited Liability Company, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Responsible party
- Sponsor
- Investigators
- Alexey Evtushenko, MD,PhD, Principal investigator, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998694
- Sponsor's protocol ID
- (T-ara) TA0120
- Acronym
- TiAra
- Status last verified
- Sep 2024
- First submitted
- 3 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
- Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis "ТiAra" (T-ara)
- ClinicalTrials.gov ID
- NCT05998694
- Acronym / sponsor ID
- TiAra / (T-ara) TA0120
- Conditions
- Aortic Valve Disease, Artificial Heart Valves
- Keywords
- aortic valve, aortic valve bioprothesis TiAra, valve bioprosthesis, hemolysis, hemolytic anemia, a heart stroke, myocardial infarction, hemorrhaging and bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Closed Joint-Stock Company NeoCorUniversity, hospital or other
- Collaborators
- CT Medical Limited Liability Company, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 21 Aug 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 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:
- To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the "TiAra" prosthesis.
- 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.
- 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.
Detailed description
Cardiovascular system diseases are one of the main causes of death worldwide. Heart valve diseases are considered one of the most important issues associated with the cardiovascular system. The replacement of heart valves includes the production of prostheses that provide functional consistency with exceptionally high reliability and appropriate fatigue strength. The proposed new biological valve with a frame made of super-elastic material allows preserves the natural biomechanics of the reconstructed valve and has high biocompatibility and resistance to infection due to the use of biological material as a frame covering. The "TiAra" bioprosthetic valve has the ability to deform during the cardiac cycle in accordance with the deformations of the fibrous structures of the patients' aortic root. The implanted valve fully integrates into the native aortic root.
The purpose of these clinical trials is to obtain clinical data confirming the efficacy and safety of the bioprosthesis under normal conditions in humans.
The expected clinical benefit involves the treatment of valvular disease with restoration of intracardiac hemodynamics during implantation of the "TiAra" 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. In order to reduce the risks caused by anticoagulant therapy, it is planned to carry out measures aimed at restoring the sinus rhythm and ensuring proper control of the indicators of the blood coagulation system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 70 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 (11 listed)
- 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.
- Real intervention on the heart valve is primary.
Key exclusion criteria (3 listed)
- 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.
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
1. Incidence of Treatment-Emergent Adverse Events, requiring repeated surgical intervention in the long term (long-term safety and durability)
Time frame: Up to 12 years from the moment of implantation .
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
2. Incidence of Treatment-Emergent Adverse Events, requiring repeated surgical intervention in the short term (short-term safety)
Time frame: Up to 12 years from the moment of implantation
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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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. This study is not recruiting at the moment.
Alexey Evtushenko, MD,PhD principal investigator
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
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 Artificial Heart Valves, 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 11 inclusion and 3 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexey Evtushenko, MD,PhD (+7 (3842) 64-33-08, ave@kemcardio.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Incidence of Treatment-Emergent Adverse Events, requiring repeated surgical intervention in the long term (long-term safety and durability) (time frame: Up to 12 years from the moment of implantation .). 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.