Mitral RegurgitationPREMISENCT03592043
A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy
An observational study of Mitral Regurgitation, run by Population Health Research Institute at 1 site in Canada.
Trial summary
The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice. It will include all patients who have undergone MitraClip implantation in Canada to date. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- MitraClip
- Type of treatment
- Medical device
- How many people
- 1,191 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to 1 Jul 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who have undergone percutaneous mitral valve repair with the MitraClip Clip Delivery System in Canada.
Who may be able to join
- Patient has undergone percutaneous mitral valve repair with MitraClip Clip Delivery System in Canada
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Multicenter Canadian Registry of Patients With Mitral Regurgitation Undergoing Percutaneous Mitral Valve Repair With MitraClip
The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice. It will include all patients who have undergone MitraClip implantation in Canada to date.
Read the detailed description
In addition to evaluating efficacy and safety, PREMISE will include a description of patient demographics, etiology of mitral regurgitation, co-morbidities, medication use and functional class. It will also compare re-hospitalization for heart failure 12 months prior and 12 months after the procedure.
- Conditions
- Mitral Regurgitation
- Being tested
- MitraClip
- Keywords
- MitraClip, Degenerative Mitral Regurgitation
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClipDevice
Also called MitraClip Clip Delivery System
Transcatheter Mitral Valve Repair with MitraClip
| Study group | Role | What they receive |
|---|---|---|
| MitraClip | All patients who have undergone percutaneous mitral valve repair with the MitraClip system in Canada Receives: Device: MitraClip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitral Regurgitation (MR) severity
Measured: 12 months
Secondary outcomes (2)
Hospitalization for Heart Failure
Measured: 12 months
All-cause mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Jan 2019
- Primary completion27 Feb 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- Retrospective
- Enrolment
- 1,191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shamir Mehta, MD MSc FRCPC, Principal investigator, Population Health Research Institute; McMaster UniversityNeil Fam, MD MSc FRCPC, Principal investigator, St. Michael's Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592043
- Sponsor's protocol ID
- PREMISE
- Acronym
- PREMISE
- Status last verified
- Aug 2021
- First submitted
- 9 Jul 2018
- Last updated
- 2 Sep 2021
- 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Canadian Registry of Patients With Mitral Regurgitation Undergoing Percutaneous Mitral Valve Repair With MitraClip
- ClinicalTrials.gov ID
- NCT03592043
- Acronym / sponsor ID
- PREMISE / PREMISE
- Conditions
- Mitral Regurgitation
- Keywords
- MitraClip, Degenerative Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,191 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 19 Jul 2018 (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.
The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice. It will include all patients who have undergone MitraClip implantation in Canada to date.
Detailed description
In addition to evaluating efficacy and safety, PREMISE will include a description of patient demographics, etiology of mitral regurgitation, co-morbidities, medication use and functional class. It will also compare re-hospitalization for heart failure 12 months prior and 12 months after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitraClip | – | Device: MitraClipAll patients who have undergone percutaneous mitral valve repair with the MitraClip system in Canada |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who have undergone percutaneous mitral valve repair with the MitraClip Clip Delivery System in Canada.
Key inclusion criteria (1 listed)
- Patient has undergone percutaneous mitral valve repair with MitraClip Clip Delivery System in Canada
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| MitraClipAlso: MitraClip Clip Delivery SystemTranscatheter Mitral Valve Repair with MitraClip | Device | MitraClip |
Primary outcome
Mitral Regurgitation (MR) severity
Time frame: 12 months
2 secondary outcomes
Hospitalization for Heart Failure
Time frame: 12 months
All-cause mortality
Time frame: 12 months
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 2 Sep 2021.
- 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. This study is not recruiting at the moment.
Shamir Mehta, MD MSc FRCPC principal investigator
Population Health Research Institute; McMaster University
Neil Fam, MD MSc FRCPC principal investigator
St. Michael's Hospital, University of Toronto
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 Mitral Regurgitation, run by Population Health Research Institute at 1 site in Canada.
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 1 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 2 Sep 2021. 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 Canada. 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?
Mitral Regurgitation (MR) severity (time frame: 12 months). 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 2 Sep 2021.