Prospective comparison of porcine pericardial prostheses in patients with severe aortic stenosis and reduced cardiac function

Prospective comparison of porcine pericardial prostheses in patients with severe aortic stenosis and reduced cardiac function - J-league trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031652

Enrollment

100

Registered

2018-03-09

Start date

2018-07-01

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

aortic stenosis

Interventions

Trifecta valve 50 cases Magna valve 50 cases

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1,Low ejection fraction (<50%) on preoperative echocardiography 2. Surgical aortic valve replacement without prior pericardiotomy and catheter aortic valve intervention 3. Including concomitant coronary artery bypass, ascending aortic replacement, and tricuspid annuloplasty 4. Severe aortic stenosis (preoperative peak pressure gradient >64mmHg, mean pressure gradient >40mmHg, or aortic valve area <1.0 cm2) 5. Planned implanted valve size is 19-21mm (Annulus diameter <21mm on preoperative echocardiography)

Exclusion criteria

Exclusion criteria: 1. concomitant mitral valve surgery 2. Aortic root replacement 3. age < 60 years 4. Patients with no preoperative echocardiography data 5. emergency surgery 6. Chronic hemodialysis

Design outcomes

Primary

Measure	Time frame
Peak pressure gradient at 1 years after implantation	—

Countries

Japan

Contacts

Public ContactHiroshi Tanaka

Kobe University, graduate school of medicine, Department of Surgery Division of Cardiovascular Surgery

hirtanak@med.kobe-u.ac.jp0783825942

Outcome results

None listed

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