Stentless mitral valve replacement using autologous pericardium study

Stentless mitral valve replacement using autologous pericardium study - Stentless mitral valve replacement using autologous pericardium study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021445

Enrollment

Registered

2016-04-01

Start date

2016-04-01

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

Mitral valve disease

Interventions

Stentless mitral valve replacement using autologous pericardium

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Mitral valve disease that meets at least one of following conditions and is indicated for surgery (1) Symptomatic acute severe MR (2) Chronic severe MR and NYHA functional class II, III or IV symptoms in the absence of severe LV dysfunction (severe LV dysfunction is defined as ejection fraction less than 0.30). (3) Asymptomatic chronic severe MR with mild to moderate LV dysfunction, ejection fraction 0.30 to 0.60, and/or end-systolic dimension greater than or equal to 40 mm. (4) Symptomatic (NYHA functional class III-IV) moderate or severe mitral stenosis when 1) percutaneous mitral balloon valvotomy is contraindicated because of left atrial thrombus despite anticoagulation or because concomitant moderate to severe MR is present, 2) the valve morphology is not favorable for percutaneous mitral balloon valvotomy, or 3) percutaneous mitral balloon valvotomy has failed. 2. Advamced mitral valve disease that standard mitral valve repair is difficult for and is unlikely to present durable results for. 3. Written informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1. Active malignancy 2. Dialysis 3. Participating in other trials 4. Myocardial infarction in the last 6 months 5. Stroke in the last 6 months 6. Previous percutaneous coronary stenting in a month before surgery 7. Concomitant procedures other than valvular operation 8. Severe left ventricular dysfunction (ejection fraction less than 0.30) 9. When excellent outcomes and prognosis are expected with standard prosthetic mitral valve replacement 10. When a principal investigator deems a patient inappropriate as a trial subject

Design outcomes

Primary

Measure	Time frame
Residual mitral regurgitation two weeks after surgery	—

Secondary

Measure	Time frame
Adverse events in 6 months after surgery	—

Countries

Japan

Contacts

Public ContactHideyuki Shimizu

Keio University School of Medicine Department of Cardiovascular Surgery

hideyuki@keio.jp03-5363-3804

Outcome results

None listed

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