Multicentered Observational Cohort Study on the Efficacy, Safety and Durability of the UniLine Epoxy-treated Prosthesis Made With Xenopericardium in the Treatment of Isolated Aortic and Mitral Valve Disease (UniLine RetroFit)

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Federal State Budgetary Scientific Institution "Research Institute for Complex Issues of Cardiovascilar Diseases"
RECRUITING
Kemerovo
Contact Information
Primary
Evgeny Bazdyrev
clinicresearch@kemcardio.ru
+7 (3842) 644240
Backup
Michael Karelin
karelin@ctmedical.ru
+7 (913) 433 7669
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 2000
Sponsors
Leads: Closed Joint-Stock Company NeoCor
Collaborators: CT Medical Limited Liability Company, Research Institute for Complex Problems of Cardiovascular Diseases, Russia

This content was sourced from clinicaltrials.gov