A prospective registry of physical and psychological functional status after surgical or transcatheter aortic valve replacement in patients with aortic valve stenosis.

A prospective registry of physical and psychological functional status after surgical or transcatheter aortic valve replacement in patients with aortic valve stenosis. - Registry of physical and psychological functional status after SAVR or TAVI.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000032353

Enrollment

200

Registered

2018-04-24

Start date

2018-05-21

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 valve stenosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 75 years or older, undergoing TAVI or SAVR with or without concomitant revascularization at Tokushima Red Cross Hospital.

Exclusion criteria

Exclusion criteria: Need for emergency surgery, clinical instability, concomitant replacement or repair of another heart valve or the aorta, difficult to undergoing physical or psychological function test, informed consent was not obtained.

Design outcomes

Primary

Measure	Time frame
Ambulation status at a week, 1, 6 and 12 months after procedure. Ambulation status is evaluated with 6-min walk test.	—

Secondary

Measure	Time frame
Cumulative survival rate after procedure. Re-admission after procedure. Physical function at a week, 1, 6 and 12 months after procedure. Mini-mental state examination at a week, 1, 6 and 12 months after procedure. SF-12 at 1, 6 and 12 months after procedure. NYHA classification at a week, 1, 6 and 12 months after procedure. Katz index of ADL at a week, 1, 6 and 12 months after procedure.	—

Countries

Japan

Contacts

Public ContactKoji Takase

Tokushima Red Cross Hospital Department of Rehabilitation

mk_koudai@yahoo.co.jp0885-32-2555

Outcome results