Status:
COMPLETED
Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions
Lead Sponsor:
Jewish General Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Aortic Stenosis
Cardiac Valve Replacement Complication
Eligibility:
All Genders
70+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Age ≥70 years (a site-specific substudy at the JGH will enroll ages ≥21 years)
- Severe AS
- Referred for surgical or transcatheter AVR (with or without concomitant revascularization)
- Signed informed consent
Exclusion
- Emergency surgery
- Clinical instability: decompensated heart failure, active ischemia, unstable vital signs
- Severe neuropsychiatric impairment
- Not English or French speaking
- Replacement of \>1 valve or aortic surgery
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT01845207
Start Date
January 1 2012
End Date
March 1 2016
Last Update
August 31 2016
Active Locations (14)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Duke University Medical Center
Durham, North Carolina, United States, 27705