PRESERVE-MITRAL Post-Market Registry

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: Completed
• Conditions: Mitral Valve Disease
• Intervention / Treatment: Device: Profile 3D™ and CG Future® annuloplasty system

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: Observational
• Enrollment (Actual): 200

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
All Cause Mortality	All deaths occurring from any cause 12-months post procedure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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)	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	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	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.	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	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	During the procedure as measured by standard operating procedures at the sites

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Surgery
• Investigators: Study Chair: Vinay Rajan, Ph.D, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID 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