Hemodynamic comparison of Trifecta and Resilia in the patients with severe aortic stenosis, small annulus, and low cardiac function

Hemodynamic comparison of Trifecta and Resilia in the patients with severe aortic stenosis, small annulus, and low cardiac function - J-League trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031834

Enrollment

100

Registered

2018-04-01

Start date

2018-05-01

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 Resilia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Preoperative echo shows ejection fraction < 50% 2. Elective primary surgical aortic valve replacement 3. inclusion: concomitant CABG, tricuspid valve surgery,aand ascending aortic replacement 4. severe aortic stenosis (peak pressure gradient >64mmHg, mean pressure gradient>40mmHg, aortic valve area < 1.ocm2 5. Implanted valve size is expected to be 19-21mm (preoperative echo shows annulus diameter is smaller than 21mm). 6. Consent is obtained by documents from the patient.

Exclusion criteria

Exclusion criteria: 1. concomitant mitral valve surgery 2. aortic root replacement 3. patients younger than 60 years 4. no preoperative echo data 5. emergency 6. patients with chronic hemodialysis

Design outcomes

Primary

Measure	Time frame
peak pressure gradient at 1 year after implantation	—

Countries

Japan

Contacts

Public ContactHiroshi Tanaka

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

hirtanak@med.kobe-u.ac.jp078-382-5942

Outcome results

None listed

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