The China Mviv Registry

NCT05925335 | Unknown

• 1 other identifier: 2023YLK 21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Mitral valve disease is the most common structure heart disease, and surgical valve replacement is an important treatment for severe mitral valve disease. There are 2 types of valve often been used, mechanical or biological protheses valves. Mechanical valve requires lifelong use of anticoagulants and take the risk of bleeding through all lifetime, but bioprotheses valve do not..

Conditions

Bioprosthesis Failure; Mitral Stenosis With Insufficiency; Mitral Stenosis; Mitral Regurgitation; Heart Failure

Outcome Measures

Primary Outcomes (2)

• all-cause mortality

  The rate in all-cause mortality will be calculated from 0 month to 12 months.

  12 months

• Rate of New hospitalization for heart failure

  Hospitalization for valve-related symptoms or worsening congestive heart failure

  12 months

Secondary Outcomes (8)

• Technical success

  24 hours

• Procedure success

  12 months

• all-cause mortality

  annual for five years

• Rate of New hospitalization for heart failure

  annual for five years

• Rate of myocardial infarction

  annual for five years

Study Arms (1)

Transcatheter mitral valve-in-valve implantation

EXPERIMENTAL

Device: Transseptal Transcatheter Mitral valve-in-valve Replacement

Interventions

Transseptal Transcatheter Mitral valve-in-valve Replacement DEVICE

Transcatheter transfemoral mitral valve-in-valve replacement is an alternative surgery in patients with severe dysfunction of a degenerated mitral bioprosthesis and high surgical risk for repeat operation. The procedure is performed via femoral vein access. All procedures were carried out using intra-procedural TEE guidance to aid in transseptal puncture. After balloon septostomy, the bioprosthetic valve is introduced through the degenerative valve into the left ventricle and expanded in the mitral position during rapid ventricle pacing.

Transcatheter mitral valve-in-valve implantation

Eligibility Criteria

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

You may qualify if:

• Subject had a degenerated surgical mitral bioprosthesis with at least moderate to severe mitral regurgitation or severe stenosis with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2
• Subjiect is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater.
• Subject is at least 18 years old.
• Heart team (including cardiac surgeon) agree on eligibility including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate.
• The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center.
• The study Subject agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone/clinic follow-up.

You may not qualify if:

• Subject was operable with the assessment of experienced Heart Team
• Subject had evidence of an acute MI, percutaneous intervention, or a peripheral intervention ≤30 days prior to Portico ViV index procedure.
• Subject had uncontrolled blood dyscrasias defined as: leukopenia (WBC\<3,000 mm3), acute anemia (Hb \<9 g/dL), or thrombocytopenia (platelet count \<50,000 cells/mm³).
• Subject was considered hemodynamically unstable at the time of the ViV procedure (requiring inotropic support or mechanical heart assistance)
• Subject had severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram.
• Subject had imaging evidence of intracardiac mass, thrombus or vegetation.
• Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding ≤3 months prior to ViV index procedure.
• Subject had a documented history of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) ≤6 months prior to index procedure.
• Subject had active bacterial endocarditis or ongoing sepsis ≤ 6 months prior to the index procedure.
• Subject was unable to tolerate antiplatelet or anticoagulant therapy

Sponsors & Collaborators

• Xiamen Cardiovascular Hospital, Xiamen University: lead

Study Sites (1)

Yan Wang

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Stenosis; Mitral Valve Insufficiency; Heart Failure

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Yan Wang, Dr

  Clinical Trial Center of Xiamen Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Chen, Dr

CONTACT

18033997788; Seanchenx@126.com

Yan Wang, Dr

CONTACT

wy@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xiamen Cardiovascular Hospital, Xiamen University

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 29, 2023
• Study Start: July 11, 2023
• Primary Completion: July 11, 2024
• Study Completion: June 11, 2025
• Last Updated: June 29, 2023

Record last verified: 2023-06

Locations

CN (1)