Stentless mitral valve replacement using autologous pericardium study

JRCT ID: jRCT1032180087

Registered date:17/01/2019

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Mitral regurgitation
• Date of first enrollment: 12/03/2018
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Stentless mitral valve replacement using autologous pericardium

Outcome(s)

• Primary Outcome: Residual mitral regurgitation two weeks after surgery
• Secondary Outcome: Residual and recurrent mitral regurgitation 12 months after surgery, adverse events in 12 months after surgery, and adverse events in 60 months after surgery.

Key inclusion & exclusion criteria

• Age minimum: 16age
• Age maximum: 70age
• Gender: Both

Include criteria

We include patients who meet all of the followings.
1. Diagnosis of mitral regurgitation
2. 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.

3. Advamced mitral valve disease that standard mitral valve repair is difficult for and is unlikely to present durable results for. (must meet at least one of the followings)
(1) Redo mitral valve surgery 6 months or longer after the previous mitral valve surgery.
(2) Infective endocarditis extending over the anterior and posterior leaflets

4. Written informed consent is obtained from the patient or his/her parental authority.

5. Patient age must be 16 or older and under 70 at the time of consent.

Exclude criteria

1. Active malignancy except for in situ cancer
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 tricuspid valve repair, maze operation and pulmonary vein isolation.
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

Related Information

• Primary Sponsor: Shimokawa Tomoki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Japan Agency for Medical Research and Development