Mitroflow® vs Perimount® international clinical evaluation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95484395

Enrollment

150

Registered

2008-01-02

Start date

2008-01-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Aortic stenosis Circulatory System Aortic stenosis

Interventions

Aortic valve replacement (Mitroflow® vs Perimount® valves)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing Aortic Valve Replacement (AVR) with annulus less than 25 cm

Exclusion criteria

Exclusion criteria: 1. Poor left ventricular function 2. Redo-aortic valve replacement 3. Other associated disorders 4. Aged greater than 70 years

Design outcomes

Primary

Measure	Time frame
The following haemodynamic data will be assessed at one and six months post implantation: 1. Effective orifice area 2. Mean pressure gradient 3. Peak pressure gradient 4. Degree LV remodelling	—

Secondary

Measure	Time frame
Morbidity and mortality. Duration of follow-up: Six months post implantation	—

Countries

Belgium, Italy, Switzerland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026