The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases

NCT06025149 | Recruiting

• 1 other identifier: UniLine
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aortic Valve Disease; Mitral Valve Disease

Keywords

UniLine biological prosthesis; Acquired valve disease; Acquired aortic valve disease; Acquired mitral valve disease

Outcome Measures

Primary Outcomes (2)

• 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

  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).

  12 years since the replacement surgery

Secondary Outcomes (1)

• Hemodynamic characteristics of the Bioprosthetic Valve

  12 years since the replacement surgery

Eligibility Criteria

• Age: 18 Years - 80 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:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Alexander Bogachev-Prokofiev, MD, PhD

  National Medical Research Center named after Academician E.N. Meshalkin

  PRINCIPAL INVESTIGATOR

• Alexey Evtushenko, MD, PhD

  Research Institute for Complex Issues of Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evgeny Bazdyrev, MD, PhD

CONTACT

+7-3842-64-42-40; clinicresearch@kemcardio.ru

Michael Karelin

CONTACT

8 (913) 433 7669; karelin@ctmedical.ru

Study Design

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

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2018
• Primary Completion: September 9, 2025
• Study Completion (Estimated): January 31, 2035
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

RU (1)