Single Institution, Exploratory, Safety Evaluation Study of Mitral Valve-in-Valve Transcatheter Mitral Valve Implantation for Degenerated Bioprosthetic Heart Valve

Single Institution, Exploratory, Safety Evaluation Study of Mitral Valve-in-Valve Transcatheter Mitral Valve Implantation for Degenerated Bioprosthetic Heart Valve - MITRAL VIV study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028278

Enrollment

Registered

2017-07-19

Start date

2017-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

failing bioprosthetic valve in the mitral position

Interventions

Interventions: Transcatheter mitral valve implantation for high-risk patients with failed prosthetic mitral valve (valve-in-valve) Period: From the clinical trial start date to March 2020 or to the d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who are 20 years of age or more 2)Patients with failed prosthetic mitral valve 3)Patients with uncontrollable heart failure 4)High-risk patients for redo cardiac surgery 5)Patients or legal guardians who can declare for clinical trial documents

Exclusion criteria

Exclusion criteria: 1)Patients with metal allergy 2)Patients with contrast media hypersensitivity 3)Patients with thrombus in left atrium or ventricle 4)Patients during shock state 5)Patients with failed prosthetic mitral valve induced by active infective endocarditis or during infection status 6)Patients with hemodialysis 7)Patients undergoing mechanical prosthetic mitral valve 8)Patients with possibility of pregnancy or during pregnancy or lactation 9)Patients joining other clinical trials or planning other clinical trials 10)Patients judged as inappropriate by the director or responsible doctors of this clinical trials

Design outcomes

Primary

Measure	Time frame
Major adverse events during the procedure(Safety) until postoperative 30th day All cause mortality within 30 days post procedure All stroke within 30 days post procedure Life-threatening major bleeding within 30 days post procedure Coronary artery lesions requiring revascularization within 30 days post procedure Major vascular complications within 30 days post procedure Structural valve failure requiring re-intervention within 30 days post procedure Any other major adverse events or device related malfunctions within 30 days post procedure	—

Measure

Time frame

Major adverse events during the procedure(Safety) until postoperative 30th day All cause mortality within 30 days post procedure All stroke within 30 days post procedure Life-threatening major bleeding within 30 days post procedure Coronary artery lesions requiring revascularization within 30 days post procedure Major vascular complications within 30 days post procedure Structural valve failure requiring re-intervention within 30 days post procedure Any other major adverse events or device related malfunctions within 30 days post procedure

—

Secondary

Measure	Time frame
Procedural Success(Efficacy) Change from baseline in mitral valve function evaluated by TTE at 7 and 30 days post operatively Change from baseline in NYHA functional class measured at 7 and 30 days post operatively Change from baseline in performance of 6 minute walk test measured postoperative day 7 Change in left ventricular end-diastolic diameter (LVEDD) at 7 and 30 days post-op Change from baseline in left ventricular ejection fraction at 7 and 30 days post op Change from baseline in plasma BNP at 7 and 30 days post-op Change from baseline in pulmonary artery wedge pressure (PAWP) immediately following procedure Change from baseline in cardiac index (CI) immediately following the procedure	—

Measure

Time frame

Procedural Success(Efficacy) Change from baseline in mitral valve function evaluated by TTE at 7 and 30 days post operatively Change from baseline in NYHA functional class measured at 7 and 30 days post operatively Change from baseline in performance of 6 minute walk test measured postoperative day 7 Change in left ventricular end-diastolic diameter (LVEDD) at 7 and 30 days post-op Change from baseline in left ventricular ejection fraction at 7 and 30 days post op Change from baseline in plasma BNP at 7 and 30 days post-op Change from baseline in pulmonary artery wedge pressure (PAWP) immediately following procedure Change from baseline in cardiac index (CI) immediately following the procedure

—

Countries

Japan

Contacts

Public ContactKizuku Yamashita

National Cerebral and Cardiovascular Center Department of Cardiovascular Surgery

kizukuy@ncvc.go.jp06-6833-5012

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026