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Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

J

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.

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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