Aortic Valve DiseasePCORI-AVRNCT02266251
Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease
An observational study of Aortic Valve Disease, run by Duke University at 1 site in United States.
Trial summary
Disease of the aortic heart valve is both common and progressively disabling, with no effective medical treatment. In November 2011, the United States Food and Drug Administration (U.S. FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve replacement (AVR). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Valve Disease
- How many people
- 273,365 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 30 May 2017
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: To compare health outcomes among patients with a similar baseline health status who are eligible for surgical and transcather AVR procedures, we will include 1)'operable' transcatheter AVR patients enrolled in the TVT Registry (Nov 2011 -Dec 2013), and 2) surgical AVR patients with a STS perioperative risk of mortality (PROM) ≥4% whose index procedure is included in the STS ACSD (Jan 2011 - Dec 2013).
Who may be able to join
- 'operable' transcatheter AVR patients enrolled in the TVT Registry (Nov 2011 -Dec 2013)
- surgical AVR patients with a STS perioperative risk of mortality (PROM) ≥4% whose index procedure is included in the STS ACSD (Jan 2011 - Dec 2013)
Who cannot join
- We will exclude patients with endocarditis or emergency/salvage status because these patients are rarely treated using transcatheter AVR in the United States (<0.2% incidence of either condition during the first year of TVT Registry data).
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Disease of the aortic heart valve is both common and progressively disabling, with no effective medical treatment. In November 2011, the United States Food and Drug Administration (U.S. FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve replacement (AVR). This new technology has changed the treatment of patients with aortic valve disease. In doing so, it has created a pressing clinical need for shared decision making tools that will help patients understand the risks and benefits of each treatment alternative in the setting of their individual characteristics.
The overarching goal of this study is to develop a new way to approach the treatment of medical illness, by focusing on the expected treatment outcomes for individual patients using information collected from large groups of patients. The corner-stone of this model is a public website that is designed to engage patients and clinicians in a personalized discussion of treatment alternatives. To achieve this goal for patients with aortic valve disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) national procedural registries that has been linked to Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical versus transcatheter AVR among patients who would be eligible for surgical AVR, and 2) create and evaluate personalized decision assistance tools for all patients considering AVR. This work will be accomplished in direct partnership with both patients and caregivers as well as a diverse group of stakeholders who will help ensure its usefulness and dissemination.
Read the detailed description
Aortic valve disease is a common, progressively debilitating condition with no effective medical treatment. Surgical aortic valve replacement (AVR) has been the standard of care in the presence of valve-associated symptoms which include heart failure, chest pain, and syncope; however, in November 2011, long-standing treatment algorithms were disrupted with the United States Food and Drug Administration (U.S. FDA) approval of a less invasive transcatheter alternative to surgical aortic valve replacement (AVR) with a different profile of associated risks and benefits. This new technology has created a pressing clinical need for shared decision making tools to help translate the "average-patient" clinical trial results to more relevant "patient-specific" information that will empower individuals facing this important treatment decision.
The overarching goal of this study is to develop a broadly applicable patient-centered paradigm for the treatment of medical illness. The corner-stone of this model is an open-access, web-based resource to engage patients, their caregivers, and clinicians in a personalized treatment discussion. To achieve this goal for patients with aortic valve disease, we will use existing Medicare-linked clinical data from the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) national procedural registries. This work will be accomplished in direct collaboration with patient and caregiver coinvestigators and a diverse stakeholder panel to ensure wide utility and dissemination.
Specifically, we will achieve the following three research aims:
Specific Aim 1. Compare contemporary health outcomes with surgical versus transcatheter AVR among operable patients in the United States; Specific Aim 2. Create and assess a personalized decision assistance tool to evaluate expected health outcomes with surgical vs. transcatheter AVR for operable patients with aortic valve disease; Specific Aim 3.Develop and assess a personalized risk assessment tool to evaluate expected health outcomes with transcatheter AVR for inoperable patients with aortic valve disease.
Additionally, we will achieve the general objective to create and evaluate web- and print-based educational resources for targeted dissemination to patients with aortic stenosis, their caregivers, and their healthcare providers.
The proposed research will facilitate a better match of patients with existing treatments and empower patients to actively participate in their own healthcare decisions, thereby improving the care of patients with aortic valve disease and reducing overall healthcare expenditures. This study will serve as a model to promote personalized medicine among both cardiovascular and non-cardiovascular disease states.
This study involves three primary comparisons. The first is a treatment comparison of surgical vs. transcatheter AVR on short and intermediate-term outcomes (stratified across important population subgroups)-important because the results will inform treatment discussions and decisions in vulnerable patients. The second is a comparison of outcomes across comorbidity sets using risk models-important because the resulting decision assistance tools will provide personalized estimates of risk to patients, caregivers, and providers as they select a treatment strategy. The third is an impact evaluation of an educational resource, including comparison of the change in treatment selection patterns and clinical outcomes across hospitals and geographic regions with high vs. low use of a web based educational resource-important because the comparison will provide critical pilot information to evaluate and tailor the resource impact.
- Conditions
- Aortic Valve Disease
- Medical subject headings
- Aortic Valve Disease
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 |
|---|---|---|
| Surgical AVR | No interventions will be administered. Retrospective data analysis will be completed to compare health outcomes among patients with a similar baseline health satus who are eligible for both procedures (operative transcatheter AVR patients enrolled in the Transcatheter Valve Therapies (TVT) Registry (Nov 2011-Dec 2013) and surgical AVR patients with STS perioperative risk of mortality whose index procedure is included in the STS Adult Cardiac Surgical DAtabase (ACSD) (Jan 2011-Dec 2013). | |
| Transcatheter AVR | No interventions will be administered. Retrospective data analysis will be completed to compare health outcomes among patients with a similar baseline health satus who are eligible for both procedures (operative transcatheter AVR patients enrolled in the TVT Registry (Nov 2011-Dec 2013) and surgical AVR patients with STS perioperative risk of mortality whose index procedure is included in the STS ACSD (Jan 2011-Dec 2013). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All-cause mortality will be analyzed in a time-to event analysis. Mortality follow-up will be considered to be administratively censored on the last date of Medicare follow-up which is expected to be 12/31/2013 for both surgical and transcatheter AVR.
Measured: one-year survival
Secondary outcomes (3)
Stroke
incidence of a clinically apparent stroke
Measured: during 1st year after surgical or transcatheter AVR
Discharged to home following the procedure (TAVR or SAVR)
The percentage of patients discharged to home after TAVR versus SAVR will be estimated.
Measured: STS ACSD (July 2011-June 2012) and STS/ACC TVT Registry (Nov 2011-March 2013)
days alive and out of the hospital during the first post-operative year
Among patients who were admitted from home, number of days (out of 365) that patient is alive and out of hospital during the first year post-operatively
Measured: number of days (out of 365) that the patient is alive and out of hospital during the first year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startMay 2014
- Primary completion30 Apr 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 273,365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, American College of Cardiology, The Society of Thoracic Surgeons
- Responsible party
- Sponsor
- Investigators
- James M Brennan, MD, MPH, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266251
- Sponsor's protocol ID
- Pro00052757
- Other IDs
- CER-1306-04350
- Acronym
- PCORI-AVR
- Status last verified
- Oct 2017
- First submitted
- 13 Oct 2014
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Health Outcomes in Patients With Symptomatic Aortic Valve Disease
- ClinicalTrials.gov ID
- NCT02266251
- Acronym / sponsor ID
- PCORI-AVR / Pro00052757
- Conditions
- Aortic Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273,365 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, American College of Cardiology, The Society of Thoracic Surgeons
- Study start
- May 2014
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 16 Oct 2014 (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.
Disease of the aortic heart valve is both common and progressively disabling, with no effective medical treatment. In November 2011, the United States Food and Drug Administration (U.S. FDA) approved a new, less invasive transcatheter alternative to surgical aortic valve replacement (AVR). This new technology has changed the treatment of patients with aortic valve disease. In doing so, it has created a pressing clinical need for shared decision making tools that will help patients understand the risks and benefits of each treatment alternative in the setting of their individual characteristics.
The overarching goal of this study is to develop a new way to approach the treatment of medical illness, by focusing on the expected treatment outcomes for individual patients using information collected from large groups of patients. The corner-stone of this model is a public website that is designed to engage patients and clinicians in a personalized discussion of treatment alternatives. To achieve this goal for patients with aortic valve disease, we will use existing clinical data from the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) national procedural registries that has been linked to Medicare claims for patient follow-up to 1) evaluate important health outcomes with surgical versus transcatheter AVR among patients who would be eligible for surgical AVR, and 2) create and evaluate personalized decision assistance tools for all patients considering AVR. This work will be accomplished in direct partnership with both patients and caregivers as well as a diverse group of stakeholders who will help ensure its usefulness and dissemination.
Detailed description
Aortic valve disease is a common, progressively debilitating condition with no effective medical treatment. Surgical aortic valve replacement (AVR) has been the standard of care in the presence of valve-associated symptoms which include heart failure, chest pain, and syncope; however, in November 2011, long-standing treatment algorithms were disrupted with the United States Food and Drug Administration (U.S. FDA) approval of a less invasive transcatheter alternative to surgical aortic valve replacement (AVR) with a different profile of associated risks and benefits. This new technology has created a pressing clinical need for shared decision making tools to help translate the "average-patient" clinical trial results to more relevant "patient-specific" information that will empower individuals facing this important treatment decision.
The overarching goal of this study is to develop a broadly applicable patient-centered paradigm for the treatment of medical illness. The corner-stone of this model is an open-access, web-based resource to engage patients, their caregivers, and clinicians in a personalized treatment discussion. To achieve this goal for patients with aortic valve disease, we will use existing Medicare-linked clinical data from the Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) national procedural registries. This work will be accomplished in direct collaboration with patient and caregiver coinvestigators and a diverse stakeholder panel to ensure wide utility and dissemination.
Specifically, we will achieve the following three research aims:
Specific Aim 1. Compare contemporary health outcomes with surgical versus transcatheter AVR among operable patients in the United States; Specific Aim 2. Create and assess a personalized decision assistance tool to evaluate expected health outcomes with surgical vs. transcatheter AVR for operable patients with aortic valve disease; Specific Aim 3.Develop and assess a personalized risk assessment tool to evaluate expected health outcomes with transcatheter AVR for inoperable patients with aortic valve disease.
Additionally, we will achieve the general objective to create and evaluate web- and print-based educational resources for targeted dissemination to patients with aortic stenosis, their caregivers, and their healthcare providers.
The proposed research will facilitate a better match of patients with existing treatments and empower patients to actively participate in their own healthcare decisions, thereby improving the care of patients with aortic valve disease and reducing overall healthcare expenditures. This study will serve as a model to promote personalized medicine among both cardiovascular and non-cardiovascular disease states.
This study involves three primary comparisons. The first is a treatment comparison of surgical vs. transcatheter AVR on short and intermediate-term outcomes (stratified across important population subgroups)-important because the results will inform treatment discussions and decisions in vulnerable patients. The second is a comparison of outcomes across comorbidity sets using risk models-important because the resulting decision assistance tools will provide personalized estimates of risk to patients, caregivers, and providers as they select a treatment strategy. The third is an impact evaluation of an educational resource, including comparison of the change in treatment selection patterns and clinical outcomes across hospitals and geographic regions with high vs. low use of a web based educational resource-important because the comparison will provide critical pilot information to evaluate and tailor the resource impact.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical AVR | – | –No interventions will be administered. Retrospective data analysis will be completed to compare health outcomes among patients with a similar baseline health satus who are eligible for both procedures (operative transcatheter AVR patients enrolled in the Transcatheter Valve Therapies (TVT) Registry (Nov 2011-Dec 2013) and surgical AVR patients with STS perioperative risk of mortality whose index procedure is included in the STS Adult Cardiac Surgical DAtabase (ACSD) (Jan 2011-Dec 2013). |
| Transcatheter AVR | – | –No interventions will be administered. Retrospective data analysis will be completed to compare health outcomes among patients with a similar baseline health satus who are eligible for both procedures (operative transcatheter AVR patients enrolled in the TVT Registry (Nov 2011-Dec 2013) and surgical AVR patients with STS perioperative risk of mortality whose index procedure is included in the STS ACSD (Jan 2011-Dec 2013). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- To compare health outcomes among patients with a similar baseline health status who are eligible for surgical and transcather AVR procedures, we will include 1)'operable' transcatheter AVR patients enrolled in the TVT Registry (Nov 2011 -Dec 2013), and 2) surgical AVR patients with a STS perioperative risk of mortality (PROM) ≥4% whose index procedure is included in the STS ACSD (Jan 2011 - Dec 2013).
Key inclusion criteria (2 listed)
- 'operable' transcatheter AVR patients enrolled in the TVT Registry (Nov 2011 -Dec 2013)
- surgical AVR patients with a STS perioperative risk of mortality (PROM) ≥4% whose index procedure is included in the STS ACSD (Jan 2011 - Dec 2013)
Key exclusion criteria (1 listed)
- We will exclude patients with endocarditis or emergency/salvage status because these patients are rarely treated using transcatheter AVR in the United States (<0.2% incidence of either condition during the first year of TVT Registry data).
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
Mortality
Time frame: one-year survival
All-cause mortality will be analyzed in a time-to event analysis. Mortality follow-up will be considered to be administratively censored on the last date of Medicare follow-up which is expected to be 12/31/2013 for both surgical and transcatheter AVR.
3 secondary outcomes
Stroke
Time frame: during 1st year after surgical or transcatheter AVR
Discharged to home following the procedure (TAVR or SAVR)
Time frame: STS ACSD (July 2011-June 2012) and STS/ACC TVT Registry (Nov 2011-March 2013)
days alive and out of the hospital during the first post-operative year
Time frame: number of days (out of 365) that the patient is alive and out of hospital during the first year post-operatively
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 13 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Disease
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Acute Pain
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
James M Brennan, MD, MPH principal investigator
Duke Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease, run by Duke University at 1 site in United States.
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 2 inclusion and 1 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Mortality (time frame: one-year survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2017.