Diseases of Mitral and Aortic Valves Clinical Trial
Official title:
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)
| NCT number | NCT05895487 |
| Other study ID # | UL RF - 01 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 1, 2022 |
| Est. completion date | May 1, 2024 |
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.
| Status | Recruiting |
| Enrollment | 2000 |
| Est. completion date | May 1, 2024 |
| Est. primary completion date | November 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Federal State Budgetary Scientific Institution "Research Institute for Complex Issues of Cardiovascilar Diseases" | Kemerovo |
| Lead Sponsor | Collaborator |
|---|---|
| Closed Joint-Stock Company NeoCor | CT Medical Limited Liability Company, Research Institute for Complex Problems of Cardiovascular Diseases, Russia |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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: 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 ACS) or progression of a chronic form of ischemia requiring percutaneous coronary intervention or coronary artery bypass grafting Access site complications Stroke |
Up to 12 years from the moment of implantation | |
| Primary | The long-term durability of the bioprosthesis will be evaluated by assessing the hemodynamic characteristics of the bioprosthetic valve (data obtained by echocardiography). | Peak and mean gradient on the atrioventricular bioprosthesis (as provided by manufacturer manufacturer).
The effective orifice area of the bioprosthesis (as provided by manufacturer manufacturer). |
Up to 12 years from the moment of implantation | |
| Secondary | Frequency of adverse events | Frequency of adverse events | Up to 12 years from the moment of implantation | |
| Secondary | Frequency of severe adverse events | Frequency of severe adverse events | Up to 12 years from the moment of implantation | |
| Secondary | Frequency of adverse events associated with the device | Frequency of adverse events associated with the device | Up to 12 years from the moment of implantation | |
| Secondary | Frequency of adverse events associated with the procedure | Frequency of adverse events associated with the procedure | Up to 12 years from the moment of implantation | |
| Secondary | The absence of all-cause mortality | The absence of all-cause mortality | Up to 12 years from the moment of implantation |