NCT01845207

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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

2.9 years

First QC Date

April 26, 2013

Last Update Submit

August 29, 2016

Conditions

Aortic StenosisCardiac Valve Replacement ComplicationFragility

Keywords

Aortic stenosisAortic valve replacementTranscatheter aortic valve implantationOutcomesFrailtyElderly

Outcome Measures

Primary Outcomes (1)

  • Post-procedural mortality or major morbidity

    Mortality is defined as death from any cause. Major morbidity is defined as an aggregate of the Society of Thoracic Surgeons (STS) and Valve Academic Research Consortium (VARC) composite endpoints. Additionally, the individual components of this composite endpoint will be examined.

    30 days

Secondary Outcomes (3)

  • All-cause mortality

    6-12 months

  • Functional status

    6-12 months

  • Length of stay

    30 days

Other Outcomes (8)

  • Cognitive function

    6-12 months

  • Mood disturbance

    6-12 months

  • Delirium

    30 days

  • +5 more other outcomes

Study Arms (1)

Aortic valve replacement

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

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In-patients and out-patients referred for surgical or transcatheter aortic valve replacement.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Centre Hospitalier Universite de Montreal

Montreal, Quebec, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, Canada

Location

Hôpital Jacques Cartier

Massy, 91300, France

Location

Related Publications (2)

  • Shi SM, Sung M, Afilalo J, Lipsitz LA, Kim CA, Popma JJ, Khabbaz KR, Laham RJ, Guibone K, Lee J, Marcantonio ER, Kim DH. Delirium Incidence and Functional Outcomes After Transcatheter and Surgical Aortic Valve Replacement. J Am Geriatr Soc. 2019 Jul;67(7):1393-1401. doi: 10.1111/jgs.15867. Epub 2019 Mar 18.

    PMID: 30882905DERIVED

  • Afilalo J, Lauck S, Kim DH, Lefevre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Genereux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7.

    PMID: 28693934DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue specimens

MeSH Terms

Conditions

Aortic Valve StenosisFrailty

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan Afilalo, MD MSc

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD MSc FACC FRCPC

Study Record Dates

First Submitted

April 26, 2013

First Posted

May 3, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

March 1, 2016

Last Updated

August 31, 2016

Record last verified: 2016-08

Locations

FR(1)US(4)CA(9)