Aortic StenosisNCT01845207
Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions
An observational study of Aortic Stenosis and Cardiac Valve Replacement Complication, run by Jewish General Hospital at 14 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Stenosis, Cardiac Valve Replacement Complication, Fragility
- How many people
- 800 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Jan 2012to Mar 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: In-patients and out-patients referred for surgical or transcatheter aortic valve replacement.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Canada9 sites
Hamilton General Hospital
Hamilton, Ontario
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Centre Hospitalier Universite de Montreal
Montreal, Quebec
Montreal Heart Institute
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
Ottawa Heart Institute
Ottawa, Ontario
St. Michael's Hospital
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
St. Boniface Hospital
Winnipeg, Manitoba
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Duke University Medical Center
Durham, North Carolina, 27705
About this study
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.
- Keywords
- Aortic stenosis, Aortic valve replacement, Transcatheter aortic valve implantation, Outcomes, Frailty, Elderly
- Medical subject headings
- Aortic Valve Stenosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aortic valve replacement | Patients aged ≥70 years referred for surgical or transcatheter aortic valve replacement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
All-cause mortality
Measured: 6-12 months
Functional status
Measured: 6-12 months
Length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Duke University, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, Massachusetts General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre, McMaster University, Montreal Heart Institute, Royal Victoria Hospital, Canada, St. Boniface Hospital, Unity Health Toronto, St. Paul's Hospital, Canada, Ottawa Heart Institute Research Corporation
- Responsible party
- Principal investigator, Jonathan Afilalo, Jewish General Hospital
- Investigators
- Jonathan Afilalo, MD MSc, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845207
- Sponsor's protocol ID
- MOP-123314
- Status last verified
- Aug 2016
- First submitted
- 26 Apr 2013
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30882905Afilalo 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.
PubMed 28693934
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions
- ClinicalTrials.gov ID
- NCT01845207
- Acronym / sponsor ID
- MOP-123314
- Keywords
- Aortic stenosis, Aortic valve replacement, Transcatheter aortic valve implantation, Outcomes, Frailty, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Duke University, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, Massachusetts General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre, McMaster University, Montreal Heart Institute, Royal Victoria Hospital, Canada, St. Boniface Hospital, Unity Health Toronto, St. Paul's Hospital, Canada, Ottawa Heart Institute Research Corporation
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic valve replacement | – | –Patients aged ≥70 years referred for surgical or transcatheter aortic valve replacement. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- In-patients and out-patients referred for surgical or transcatheter aortic valve replacement.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-procedural mortality or major morbidity
Time frame: 30 days
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.
3 secondary outcomes
All-cause mortality
Time frame: 6-12 months
Functional status
Time frame: 6-12 months
Length of stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Derived from this study: PubMed 30882905Shi 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.
- Derived from this study: PubMed 28693934Afilalo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Afilalo, MD MSc principal investigator
Jewish General Hospital
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Cardiac Valve Replacement Complication, run by Jewish General Hospital at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Canada, United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-procedural mortality or major morbidity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01845207, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.