PRESERVE-MITRAL Post-Market Registry

February 10, 2025 updated by: Medtronic Cardiac Surgery

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1216
        • National Heart Foundation Hospital & Research Institute
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380016
        • U. N. Mehta Institute of Cardiology and Research Centre
      • Ahmedabad, Gujarat, India, 380054
        • SAL Hospital & Medical Institute
      • Ahmedabad, Gujarat, India, 380060
        • Epic Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560069
        • Sri Jayadeva Institute of Cardiovascular Sciences & Research
      • Bangalore, Karnataka, India, 560099
        • Narayana Institute of Cardiac Sciences
    • Kerala
      • Kochi, Kerala, India, 682041
        • Amrita Institute of Medical Sciences and Research Center
    • Maharashtra
      • Mumbai, Maharashtra, India, 400016
        • P.D. Hinduja National Hospital and Medical Research Centre
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600037
        • The Madras Medical Mission
      • Coimbatore, Tamil Nadu, India, 641037
        • G. Kuppuswamy Memorial Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Care Hospitals
  • Nepal
      • Kathmandu, Nepal
        • Manmohan Cardiothoracic Vascular and Transplant Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  1. 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
  2. Indications and contraindications provided in the product Instructions for Use
  3. Subject is 18 years of age or older
  4. 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

Exclusion Criteria:

  1. Contraindications as per instructions-for-use (IFU):

    1. Heavily calcified valves
    2. Valvular retraction with severely reduced mobility
    3. Active bacterial endocarditis
  2. Aortic valve replacement as concomitant procedure
  3. Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months
All Cause Mortality
Time Frame: 12 months
All deaths occurring from any cause 12-months post procedure
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
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)
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.
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
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)
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)
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
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
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
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)
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.
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)
Number of surgical attempts required for procedural implant success
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
Total time a subject is on bypass time as a measure of procedural complexity
During the procedure as measured by standard operating procedures at the sites

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Surgery

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Vinay Rajan, Ph.D, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDT16016SUR002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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