Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis

NCT05998694 | Recruiting

• 1 other identifier: (T-ara) TA0120
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 1.To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the "TiAra" prosthesis.
2. 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. 3.To assess complications of the early and mid-term follow-up periods of aortic valve replacement using the "TiAra" prosthesis.

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; a reoperation

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to 12 years from the moment of implantation

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As part of these clinical trials (studies), the use of comparison groups is not planned.

You may qualify if:

• 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.
• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Closed Joint-Stock Company NeoCor: lead
• CT Medical Limited Liability Company: collaborator
• Research Institute for Complex Problems of Cardiovascular Diseases, Russia: collaborator

Study Sites (1)

Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Kemerovo, Kemerovo Oblast, 650002, Russia

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease; Hemolysis; Anemia, Hemolytic; Myocardial Infarction; Hemorrhage; Arrhythmias, Cardiac; Joint Dislocations; Heart Failure; Thromboembolism

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Embolism and Thrombosis

Study Officials

• Alexey Evtushenko, MD,PhD

  Research Institute for Complex Problems of Cardiovascular Diseases, Russia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexey Evtushenko, MD,PhD

CONTACT

+7 (3842) 64-33-08; ave@kemcardio.ru

Denis Lebedev, MD

CONTACT

+79138456592; mdlebedevd@mail.ru

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 21, 2023
• Study Start: June 1, 2021
• Primary Completion: August 10, 2025
• Study Completion (Estimated): August 10, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

RU (1)