Mitral Valve ProlapsePRIMARY SDMNCT06738537
Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse
An observational study of Mitral Valve Prolapse, run by Northwell Health at 5 sites in United States.
Trial summary
This is a qualitative and quantitative study that seeks to obtain information from patients with degenerative mitral valve prolapse and providers regarding factors important in deciding between surgical mitral valve repair (MVR) and transcatheter edge-to-edge repair (TEER). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Valve Prolapse
- What is being tested?
- Focus Groups/Quantitative Survey for Patients, Focus Group/Quantitative Survey for HCPs and Qualitative Focus Group
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Sep 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe degenerative MR
Who may be able to join
- Age 21 years and older
- Diagnosis of degenerative mitral valve regurgitation
Who cannot join
- Non-English speaking
- Unable to consent on own behalf
- Previous mitral surgery
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Mary Alice Bowman, 216-444-2200, BOWMANM3@ccf.org
Laurie Ann Moennich, 216-444-2200
- Recruiting
Saint Luke's Hospital
Kansas City, Missouri, 64111
Nancy Stone, MEd, NBC-HWC, 816-932-5367, nanstone@saint-lukes.org
Christine Fuss, RN, 816-932-5363, cfuss@saint-lukes.org
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Achille Peiris, 310-423-3277, achille.peiris@cshs.org
Maria Thottam, 310-423-3277, maria.thottam@cshs.org
- Recruiting
West Virginia University Medicine
Morgantown, West Virginia, 26506
Josh Bombard, 304-598-4000, josh.bombard@wvumedicine.org
Kimberly Quedado, 3045984000, kq10006@wvumedicine.org
- Recruiting
Northwell Health
New York, New York, 10075
Shangyi Liu, MS, 516-757-5949, sliu11@northwell.edu
Efstathia Mihelis, PA-C, MBA, 516-474-3745, emihelis@northwell.edu
About this study
Official title: Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse (PRIMARY SDM)
This is a qualitative and quantitative study that seeks to obtain information from patients with degenerative mitral valve prolapse and providers regarding factors important in deciding between surgical mitral valve repair (MVR) and transcatheter edge-to-edge repair (TEER). Findings from this study will provide data that can be used to develop decision aids that can assist patients in decision making between these two therapies and assist providers in integrating shared decision making the within the multidisciplinary heart valve team.
Read the detailed description
Prior qualitative research in decision-making related to heart valve disease has occurred largely in transcatheter aortic valve replacement (TAVR). Among patients undergoing TAVR, physicians estimate patients' symptoms and functional status poorly both before and after treatment. Prior studies have shown that significant variability exists in outcomes most important to patients versus those most important to providers. Specifically, providers may place greater emphasis on clinical endpoints such as mortality or echocardiographic improvement in valve function whereas patients often place greater emphasis on quality-of-life outcomes such as having greater independence, feeling better, and being able to return to daily activities.
These disparities between patient and provider preference in outcomes in TAVR highlight the importance of prospectively measuring patient and provider preferences in outcomes of transcatheter edge-to-edge repair (TEER) and surgical mitral valve repair (MVR), which share similar tradeoffs in decision-making. The ongoing Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) trial will compare TEER to MVR in patients with primary, degenerative MR. To allow for the creation of a decision aid that can be utilize simultaneously with completion of the parent clinical trial, the investigators seek to conduct a quantitative and quality study of patient and physician factors that influence decision-making in TEER versus MVR for degenerative mitral regurgitation.
This study will consist of prospectively conducted qualitative focus groups among patients and providers (surgeons and cardiologists) to elicit the range of outcomes when considering TEER or MVR. These data will be analyzed to develop a consolidated framework of outcomes patients and providers value. Using these data, the investigators will then create and administer a quantitative survey to characterize how patients with severe MR and their providers prioritize outcomes when making treatment decisions and recommendations. The survey will include an allocation task whereby participants will be presented with a set of alternative treatment outcomes from the qualitative surveys and components of the PRIMARY composite endpoint and asked to allocate a total of 100 points across these outcomes based on their preferences. Lastly, the investigators will identify barriers and facilitators for implementing shared decision making (SDM) in multidisciplinary mitral valve hear teams by conducting qualitative focus groups across health care provider stakeholders (e.g. surgeons, cardiologists, nurses in office). These data will be used to map workflows and identify the optimal timing and process of integrating SDM in clinical care. In addition to generating process maps, an understanding of the implementation barriers and facilitators will aid in developing an approach to create and test an implementation strategy for SDM in severe degenerative MR. Collectively, these aims lay the foundation for developing and implementing a patient centered decision aid to support SDM in the future, but also model a novel approach for implementing the results of PRIMARY into routine clinical care.
- Conditions
- Mitral Valve Prolapse
- Being tested
- Focus Groups/Quantitative Survey for Patients, Focus Group/Quantitative Survey for HCPs, Qualitative Focus Group
- Keywords
- transcatheter edge-to-edge repair, surgical mitral valve repair
- Medical subject headings
- Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus Groups/Quantitative Survey for PatientsOther
5 quantitative focus groups will be conducted with 5-10 patients each to elicit the range of outcomes patients consider important when selecting treatment options. 100 quantitative surveys to characterize how patients with severe MR prioritize outcomes when making treatment decisions.
Focus Group/Quantitative Survey for HCPsOther
5 quantitative focus groups will be conducted with 5-10 providers to elicit the range of outcomes providers consider important when recommending treatment options to patients. 100 quantitative surveys to characterize how providers prioritize outcomes for patients with severe MR when making treatment recommendations.
Qualitative Focus GroupOther
Qualitative focus groups will be conducted to determine barriers and facilitators to implementing shared decision making in multidisciplinary mitral valve heart team clinics.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MR | We will recruit patients with degenerative mitral regurgitation (MR) who are presenting to a surgeon or cardiologist for consultation regarding management of their valve disease. Receives: Other: Focus Groups/Quantitative Survey for Patients | |
| Health Care Providers | We will recruit Health Care providers (cardiac surgeons and cardiologists) who evaluate and treat patients with mitral regurgitation. Receives: Other: Focus Group/Quantitative Survey for HCPs | |
| Multidisciplinary Mitral Valve Heart Team | We will recruit members of multidisciplinary mitral valve heart teams including cardiac surgeons, cardiologists, nurses, and ancillary staff. These providers will be involved in caring for patients who presents to multidisciplinary heart teams for evaluation of their mitral valve disease. Receives: Other: Qualitative Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify outcomes most important to patients with severe degenerative MR considering TEER or MVR
The investigators will conduct qualitative focus groups among patients with severe degenerative MR to elicit the range of outcomes patients consider important when selecting treatment options. These data will be analyzed to develop a consolidated framework of outcomes patients value. Using these data, the investigators will then create and administer a quantitative survey to characterize how patients with severe MR prioritize outcomes when making treatment decisions.
Measured: 1 year
Identify outcomes most important to healthcare providers (HCPs) in recommendingTEER or MVR
The investigators will conduct qualitative focus groups among cardiac surgeons, referring cardiologists, interventional cardiologists who perform TEER, and nurses involved in the care of patients with degenerative MR to characterize outcomes important to HCPs when evaluating MVR versus TEER. Using similar methods as above, the investigators will then use these data to create and administer a quantitative point allocation survey to characterize how HCPs prioritize outcomes when evaluating treatment options for severe degenerative MR patients.
Measured: 1 year
Identify barriers and facilitators to implementing shared decision making (SDM) in multidisciplinary mitral valve Heart Teams
To support the future implementation of SDM, the investigators will evaluate the process of introducing SDM into local Heart Teams by conducting qualitative interviews across HCP stakeholders. Key stakeholders will include multidisciplinary groups of HCPs, ancillary staff, and administrators. These data will be used to map workflows and identify the optimal timing and process of integrating SDM in clinical care. In addition to generating process maps, an understanding of the implementation barriers and facilitators will aid in developing an approach to create and test an implementation strategy for SDM in severe degenerative MR.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Sep 2023
- Primary completion28 Jan 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ProlapseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia University, Cedars-Sinai Medical Center, The Cleveland Clinic, University of Kansas Medical Center, Saint Luke's Mid America Heart Institute
- Responsible party
- Sponsor
- Investigators
- Alexander Iribarne, MD, MS, FACC, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738537
- Sponsor's protocol ID
- 23-0905
- Acronym
- PRIMARY SDM
- Status last verified
- Dec 2024
- First submitted
- 8 Nov 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Approach for Treatment Decisions in Mitral Valve Prolapse (PRIMARY SDM)
- ClinicalTrials.gov ID
- NCT06738537
- Acronym / sponsor ID
- PRIMARY SDM / 23-0905
- Conditions
- Mitral Valve Prolapse
- Keywords
- transcatheter edge-to-edge repair, surgical mitral valve repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- West Virginia University, Cedars-Sinai Medical Center, The Cleveland Clinic, University of Kansas Medical Center, Saint Luke's Mid America Heart Institute
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 28 Jan 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 17 Dec 2024 (actual)
- 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.
This is a qualitative and quantitative study that seeks to obtain information from patients with degenerative mitral valve prolapse and providers regarding factors important in deciding between surgical mitral valve repair (MVR) and transcatheter edge-to-edge repair (TEER). Findings from this study will provide data that can be used to develop decision aids that can assist patients in decision making between these two therapies and assist providers in integrating shared decision making the within the multidisciplinary heart valve team.
Detailed description
Prior qualitative research in decision-making related to heart valve disease has occurred largely in transcatheter aortic valve replacement (TAVR). Among patients undergoing TAVR, physicians estimate patients' symptoms and functional status poorly both before and after treatment. Prior studies have shown that significant variability exists in outcomes most important to patients versus those most important to providers. Specifically, providers may place greater emphasis on clinical endpoints such as mortality or echocardiographic improvement in valve function whereas patients often place greater emphasis on quality-of-life outcomes such as having greater independence, feeling better, and being able to return to daily activities.
These disparities between patient and provider preference in outcomes in TAVR highlight the importance of prospectively measuring patient and provider preferences in outcomes of transcatheter edge-to-edge repair (TEER) and surgical mitral valve repair (MVR), which share similar tradeoffs in decision-making. The ongoing Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) trial will compare TEER to MVR in patients with primary, degenerative MR. To allow for the creation of a decision aid that can be utilize simultaneously with completion of the parent clinical trial, the investigators seek to conduct a quantitative and quality study of patient and physician factors that influence decision-making in TEER versus MVR for degenerative mitral regurgitation.
This study will consist of prospectively conducted qualitative focus groups among patients and providers (surgeons and cardiologists) to elicit the range of outcomes when considering TEER or MVR. These data will be analyzed to develop a consolidated framework of outcomes patients and providers value. Using these data, the investigators will then create and administer a quantitative survey to characterize how patients with severe MR and their providers prioritize outcomes when making treatment decisions and recommendations. The survey will include an allocation task whereby participants will be presented with a set of alternative treatment outcomes from the qualitative surveys and components of the PRIMARY composite endpoint and asked to allocate a total of 100 points across these outcomes based on their preferences. Lastly, the investigators will identify barriers and facilitators for implementing shared decision making (SDM) in multidisciplinary mitral valve hear teams by conducting qualitative focus groups across health care provider stakeholders (e.g. surgeons, cardiologists, nurses in office). These data will be used to map workflows and identify the optimal timing and process of integrating SDM in clinical care. In addition to generating process maps, an understanding of the implementation barriers and facilitators will aid in developing an approach to create and test an implementation strategy for SDM in severe degenerative MR. Collectively, these aims lay the foundation for developing and implementing a patient centered decision aid to support SDM in the future, but also model a novel approach for implementing the results of PRIMARY into routine clinical care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with MR | – | Other: Focus Groups/Quantitative Survey for PatientsWe will recruit patients with degenerative mitral regurgitation (MR) who are presenting to a surgeon or cardiologist for consultation regarding management of their valve disease. |
| Health Care Providers | – | Other: Focus Group/Quantitative Survey for HCPsWe will recruit Health Care providers (cardiac surgeons and cardiologists) who evaluate and treat patients with mitral regurgitation. |
| Multidisciplinary Mitral Valve Heart Team | – | Other: Qualitative Focus GroupWe will recruit members of multidisciplinary mitral valve heart teams including cardiac surgeons, cardiologists, nurses, and ancillary staff. These providers will be involved in caring for patients who presents to multidisciplinary heart teams for evaluation of their mitral valve disease. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe degenerative MR
Key inclusion criteria (2 listed)
- Age 21 years and older
- Diagnosis of degenerative mitral valve regurgitation
Key exclusion criteria (3 listed)
- Non-English speaking
- Unable to consent on own behalf
- Previous mitral surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus Groups/Quantitative Survey for Patients5 quantitative focus groups will be conducted with 5-10 patients each to elicit the range of outcomes patients consider important when selecting treatment options. 100 quantitative surveys to characterize how patients with severe MR prioritize outcomes when making treatment decisions. | Other | Patients with MR |
| Focus Group/Quantitative Survey for HCPs5 quantitative focus groups will be conducted with 5-10 providers to elicit the range of outcomes providers consider important when recommending treatment options to patients. 100 quantitative surveys to characterize how providers prioritize outcomes for patients with severe MR when making treatment recommendations. | Other | Health Care Providers |
| Qualitative Focus GroupQualitative focus groups will be conducted to determine barriers and facilitators to implementing shared decision making in multidisciplinary mitral valve heart team clinics. | Other | Multidisciplinary Mitral Valve Heart Team |
Primary outcome
Identify outcomes most important to patients with severe degenerative MR considering TEER or MVR
Time frame: 1 year
The investigators will conduct qualitative focus groups among patients with severe degenerative MR to elicit the range of outcomes patients consider important when selecting treatment options. These data will be analyzed to develop a consolidated framework of outcomes patients value. Using these data, the investigators will then create and administer a quantitative survey to characterize how patients with severe MR prioritize outcomes when making treatment decisions.
Identify outcomes most important to healthcare providers (HCPs) in recommendingTEER or MVR
Time frame: 1 year
The investigators will conduct qualitative focus groups among cardiac surgeons, referring cardiologists, interventional cardiologists who perform TEER, and nurses involved in the care of patients with degenerative MR to characterize outcomes important to HCPs when evaluating MVR versus TEER. Using similar methods as above, the investigators will then use these data to create and administer a quantitative point allocation survey to characterize how HCPs prioritize outcomes when evaluating treatment options for severe degenerative MR patients.
Identify barriers and facilitators to implementing shared decision making (SDM) in multidisciplinary mitral valve Heart Teams
Time frame: 1 year
To support the future implementation of SDM, the investigators will evaluate the process of introducing SDM into local Heart Teams by conducting qualitative interviews across HCP stakeholders. Key stakeholders will include multidisciplinary groups of HCPs, ancillary staff, and administrators. These data will be used to map workflows and identify the optimal timing and process of integrating SDM in clinical care. In addition to generating process maps, an understanding of the implementation barriers and facilitators will aid in developing an approach to create and test an implementation strategy for SDM in severe degenerative MR.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Alexander Iribarne, MD, MS, FACC principal investigator
Northwell Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Prolapse, run by Northwell Health at 5 sites 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 3 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: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Stone, MEd, NBC-HWC (816-932-5367, nanstone@saint-lukes.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify outcomes most important to patients with severe degenerative MR considering TEER or MVR (time frame: 1 year). The study lists 3 primary outcomes in all. 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 17 Dec 2024.