Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Jewish General Hospital

Status: Completed

Conditions: Cardiac Valve Replacement Complication; Fragility; Aortic Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT01845207

MOP-123314

Details and patient eligibility

About

Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to recommend. This multi-center prospective cohort study is aimed at comparing various frailty assessment tools to determine which best predicts death or major complications after cardiac surgery or transcatheter intervention. The population of interest is elderly patients with severe aortic stenosis undergoing surgical or transcatheter aortic valve replacement. The frailty assessment tools under investigation include composite frailty scales, physical performance tests, muscle mass, and biomarker expression. The overall objective is to improve our ability to predict risk by measuring frailty using the optimal tool in elderly cardiovascular patients.

Enrollment: 800 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥70 years (a site-specific substudy at the JGH will enroll ages ≥21 years)
2. Severe AS
3. Referred for surgical or transcatheter AVR (with or without concomitant revascularization)
4. Signed informed consent

Exclusion criteria

1. Emergency surgery
2. Clinical instability: decompensated heart failure, active ischemia, unstable vital signs
3. Severe neuropsychiatric impairment
4. Not English or French speaking
5. Replacement of >1 valve or aortic surgery

Trial design

800 participants in 1 patient group

Aortic valve replacement

Description:

Patients aged ≥70 years referred for surgical or transcatheter aortic valve replacement.