Study on Efficacy, Safety and Durability of the UniLine Prosthesis in the Treatment of Aortic and Mitral Valve Disease

NCT05895487 | Recruiting

• 1 other identifier: UL RF - 01
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Acquired heart diseases continue to remain one of the most common causes of cardiac mortality and morbidity. In the Russian Federation, open surgery treatment of acquired valvular heart diseases (AVHD) is performed in more than 40 regions by specialists from 92 healthcare organizations. Treating aortic or mitral valve disease using the "UniLine" biological prosthesis is expected to improve survival rates. Supposedly, in vivo the "UniLine" biological prosthesis will show optimal hemodynamic characteristics and high resistance to structural valve degeneration and infectious damage, thus lowering the risk of dysfunction. Moreover, the risk of repeated intervention due to dysfunction of the "UniLine" bioprosthesis should not exceed the risk of the primary implantation. Supposedly, in the case of dysfunction of "UniLine" bioprosthesis it would be possible to perform repeated replacement using valve-in-valve technique. The aim of the study is to assess the effectiveness, safety, durability of the "UniLine" epoxy-treated prosthesis and the long-term outcome of the treatment of isolated mitral and aortic valve diseases using this prosthesis. In accordance with the objectives and hypothesis, the following data will be analyzed: actuarial and linear survival rates (general and cardiac), non-lethal prosthesis-associated complications, prosthetic dysfunction and repeated interventions. Moreover, in vivo hemodynamic parameters of the prosthesis will be assessed: the area of the effective opening surface, peak and mean gradient of pressure and blood flow velocity. The study will be conducted at the Research Institute of Complex Issues of Cardiovascular Diseases. Study protocol received sponsorship approval and approval by Local Ethics Committee of the Research Institute and Research Coordinating Committee. The study will enroll patients who underwent isolated mitral or aortic valve replacement; transthoracic echocardiography will be conducted in all patients available for in-person visit.

Conditions

Diseases of Mitral and Aortic Valves; Rheumatic Disorders of Mitral and Aortic Valves; Other Congenital Malformations of Aortic and Mitral Valves; Valvular Heart Disease (Aortic and Mitral Valves); Mitral Valve Insufficiency and Aortic Valve Insufficiency

Keywords

acquired heart diseases; mitral valve; aortic valve; prosthetic heart valves; bioprosthetic valves "UniLine"; bioprosthetic valve dysfunction

Outcome Measures

Primary Outcomes (2)

• Long-term safety and durability of the "UniLine" epoxy-treated prosthesis made with xenopericardium in the treatment of isolated mitral and aortic valve diseases

  Long-term safety of the "UniLine" 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: 1. Death 2. Severe complications of the heart 3. Life-threatening bleeding 4. Any bioprosthesis-related dysfunction, migration, thrombosis or other complication requiring an open-heart surgery or repeated intervention. 5. Myocardial infarction (or ACS) or progression of a chronic form of ischemia requiring percutaneous coronary intervention or coronary artery bypass grafting 6. Access site complications 7. Stroke

  Up to 12 years from the moment of implantation

• The long-term durability of the bioprosthesis will be evaluated by assessing the hemodynamic characteristics of the bioprosthetic valve (data obtained by echocardiography).

  1. Peak and mean gradient on the atrioventricular bioprosthesis (as provided by manufacturer manufacturer). 2. The effective orifice area of the bioprosthesis (as provided by manufacturer manufacturer).

  Up to 12 years from the moment of implantation

Secondary Outcomes (5)

• Frequency of adverse events

  Up to 12 years from the moment of implantation

• Frequency of severe adverse events

  Up to 12 years from the moment of implantation

• Frequency of adverse events associated with the device

  Up to 12 years from the moment of implantation

• Frequency of adverse events associated with the procedure

  Up to 12 years from the moment of implantation

• The absence of all-cause mortality

  Up to 12 years from the moment of implantation

Eligibility Criteria

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

Study Population

Patients aged 18 years and older who underwent isolated mitral or aortic valve replacement.

You may qualify if:

• Patients of both sexes aged 18 years and older who underwent isolated mitral or aortic valve replacement using the "UniLine" bioprosthesis
• No prior heart valve replacement

You may not qualify if:

• The presence of a mechanical or biological prosthesis in another position
• Prior valve repair
• Aortic aneurysm repair (ascending aorta)
• Resection of a left ventricular aneurysm
• Patients with active cancer and patients with history of cancer

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)

Federal State Budgetary Scientific Institution "Research Institute for Complex Issues of Cardiovascilar Diseases"

Kemerovo, 650002, Russia

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Mitral Valve Insufficiency; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease

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

CONTACT

+7 (3842) 644240; clinicresearch@kemcardio.ru

Michael Karelin

CONTACT

+7 (913) 433 7669; karelin@ctmedical.ru

Study Design

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

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 8, 2023
• Study Start: November 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: May 1, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

RU (1)