Mitral Valve DiseaseNCT03283722
PRESERVE-MITRAL Post-Market Registry
An observational study of Mitral Valve Disease, run by Medtronic Cardiac Surgery at 12 sites in 3 countries.
Trial summary
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- Profile 3D™ and CG Future® annuloplasty system
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 10 Apr 2017to 10 Feb 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings
Who may be able to join
- Patients with valvular insufficiency and/or stenosis and indicated for the reconstruction and/or remodeling of pathological mitral valves with Profile 3D™ and CG Future® annuloplasty systems
- Indications and contraindications provided in the product Instructions for Use
- Subject is 18 years of age or older
- The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the registry and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements
Who cannot join
- Contraindications as per instructions-for-use (IFU):
- Heavily calcified valves
- Valvular retraction with severely reduced mobility
- Active bacterial endocarditis
- Aortic valve replacement as concomitant procedure
- Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
India10 sites
U. N. Mehta Institute of Cardiology and Research Centre
Ahmedabad, Gujarat, 380016
SAL Hospital & Medical Institute
Ahmedabad, Gujarat, 380054
EPIC Hospital
Ahmedabad, Gujarat, 380060
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bangalore, Karnataka, 560069
Narayana Institute of Cardiac Sciences
Bangalore, Karnataka, 560099
The Madras Medical Mission
Chennai, Tamil Nadu, 600037
G. Kuppuswamy Memorial Hospital
Coimbatore, Tamil Nadu, 641037
CARE Hospitals
Hyderabad, Telangana, 500034
Amrita Institute of Medical Sciences and Research Center
Kochi, Kerala, 682041
P.D. Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, 400016
Bangladesh1 site
National Heart Foundation Hospital & Research Institute
Dhaka, 1216
About this study
Official title: Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure
Read the detailed description
There is limited local evidence on mitral repair products in South Asia and a prospective post market registry will provide real world data on clinical outcomes.
Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings will be considered for study participation.
PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market registry
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trail was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Heath Service Act or 42 CRF 11.24 and 11.44.)
- Conditions
- Mitral Valve Disease
- Being tested
- Profile 3D™ and CG Future® annuloplasty system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profile 3D™ and CG Future® annuloplasty systemDevice
Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure
This is determined by assessing the level of mitral valve regurgitation using echo, in subjects at 12-months post-procedure compared to the level at baseline. The levels of regurgitation, level 0-4, correspond to the American Society of Echocardiography (ASE) guidelines ranging from no MR, Mild MR, Moderate MR, Moderate- to-Severe MR and Severe MR. A percentage number is calculated to reflect how many participants had an MR improvement.
Measured: 12 months
All Cause Mortality
All deaths occurring from any cause 12-months post procedure
Measured: 12 months
Secondary outcomes (8)
Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months)
This was determined by assessing the level of mitral valve regurgitation using hemodynamic performance, in subjects at discharge and 3-6 months post-procedure compared to the level at baseline. The levels of regurgitation, level 0-4, correspond to the ASE guidelines ranging from no MR, Mild MR, Moderate MR, Moderate-to-Severe MR and Severe MR
Measured: At discharge from hospital (up to 7 days) and at first follow-up (3-6month)
Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline.
The percentage of subjects with an improved New York Heart Association NYHA functional class using a two-sided 95% exact binomial confidence internal measured at discharge, 3-6 months, and 12-months post-procedure and compared to baseline.
Measured: At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months)
Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure
Subjects who have a non-elective hospital admission for signs and symptoms related to heart failure that results in a one night stay (i.e., where the admission date and the discharge date differ by at least one calendar day)
Measured: 6 months and 12 months post procedure
Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure
Subject leaving the operating theater with an implanted Profile 3DTM or CG Future® annuloplasty system and later undergo any surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces the previously implanted annuloplasty system is considered a reoperation
Measured: At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months)
Stroke at 6 Months and at 12 Months Post Procedure
Subjects had an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction, where the neurological dysfunction lasts for greater than 24-hours
Measured: 6 months and 12 months post procedure
New Onset of Atrial Fibrillation, as Evaluated Through Follow up ECG at Discharge, First Follow up (3-6months) and at Second Follow up (12 Months)
New onset of AF is defined as when the subject did not present with prior history of AF at baseline nor was AF detected at baseline visit, but AF did manifest post procedure and was either diagnosed during the study visits (discharge, 3-6 months or 12 months visit) or was otherwise diagnosed during the duration of subject participation in the study. The incidence of new onset AF will be evaluated at discharge, first follow up (3-6 months) and at second follow up (12 months). This endpoint is analyzed for the Successfully Implanted (IMP) cohort and provided as a Kaplan-Meier analysis.
Measured: At discharge from hospital, (up to 7 days), at first follow-up (3-6month), and at the second follow-up (12 months)
Number of Attempts Required for Procedural Success
Number of surgical attempts required for procedural implant success
Measured: Procedure (defined as the date of the first attempted procedure through subject leaving the operating theater with an implanted Profile 3D or CG Future annuloplasty system)
Total Bypass Time During the Implant Procedure
Total time a subject is on bypass time as a measure of procedural complexity
Measured: During the procedure as measured by standard operating procedures at the sites
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start10 Apr 2017
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mitral Valve DiseaseStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinay Rajan, Ph.D, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283722
- Sponsor's protocol ID
- MDT16016SUR002
- Status last verified
- Feb 2025
- First submitted
- 9 Aug 2017
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia
- ClinicalTrials.gov ID
- NCT03283722
- Acronym / sponsor ID
- MDT16016SUR002
- Conditions
- Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medtronic Cardiac SurgeryIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 11 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure
Detailed description
There is limited local evidence on mitral repair products in South Asia and a prospective post market registry will provide real world data on clinical outcomes.
Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings will be considered for study participation.
PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market registry
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trail was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Heath Service Act or 42 CRF 11.24 and 11.44.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings
Key inclusion criteria (4 listed)
- Patients with valvular insufficiency and/or stenosis and indicated for the reconstruction and/or remodeling of pathological mitral valves with Profile 3D™ and CG Future® annuloplasty systems
- Indications and contraindications provided in the product Instructions for Use
- Subject is 18 years of age or older
- The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the registry and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements
Key exclusion criteria (6 listed)
- Contraindications as per instructions-for-use (IFU):
- Aortic valve replacement as concomitant procedure
- Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints
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 |
|---|---|---|
| Profile 3D™ and CG Future® annuloplasty systemPatients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings | Device | – |
Primary outcome
Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure
Time frame: 12 months
This is determined by assessing the level of mitral valve regurgitation using echo, in subjects at 12-months post-procedure compared to the level at baseline. The levels of regurgitation, level 0-4, correspond to the American Society of Echocardiography (ASE) guidelines ranging from no MR, Mild MR, Moderate MR, Moderate- to-Severe MR and Severe MR. A percentage number is calculated to reflect how many participants had an MR improvement.
All Cause Mortality
Time frame: 12 months
All deaths occurring from any cause 12-months post procedure
8 secondary outcomes
Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months)
Time frame: At discharge from hospital (up to 7 days) and at first follow-up (3-6month)
Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline.
Time frame: At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months)
Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure
Time frame: 6 months and 12 months post procedure
Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure
Time frame: At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months)
Stroke at 6 Months and at 12 Months Post Procedure
Time frame: 6 months and 12 months post procedure
New Onset of Atrial Fibrillation, as Evaluated Through Follow up ECG at Discharge, First Follow up (3-6months) and at Second Follow up (12 Months)
Time frame: At discharge from hospital, (up to 7 days), at first follow-up (3-6month), and at the second follow-up (12 months)
Number of Attempts Required for Procedural Success
Time frame: Procedure (defined as the date of the first attempted procedure through subject leaving the operating theater with an implanted Profile 3D or CG Future annuloplasty system)
Total Bypass Time During the Implant Procedure
Time frame: During the procedure as measured by standard operating procedures at the sites
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
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A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
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Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
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The PALMETTO Study
Mitral Regurgitation
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.
Vinay Rajan, Ph.D study chair
Medtronic
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Disease, run by Medtronic Cardiac Surgery at 12 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 6 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India, Bangladesh, Nepal. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure (time frame: 12 months). The study lists 2 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 11 Feb 2025.