PRESERVE-MITRAL Post-Market Registry

NCT03283722 | Completed Results

• 1 other identifier: MDT16016SUR002
• Study Type: observational
• Target: 200
• Locations: 3 countries
• Sites: 12

Brief 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

Conditions

Mitral Valve Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months)

  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.

  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

  6 months and 12 months post procedure

• Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure

  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

  6 months and 12 months post procedure

Interventions

Profile 3D™ and CG Future® annuloplasty system DEVICE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Surgery: lead

Study Sites (12)

National Heart Foundation Hospital & Research Institute

Dhaka, 1216, Bangladesh

Location

U. N. Mehta Institute of Cardiology and Research Centre

Ahmedabad, Gujarat, 380016, India

Location

SAL Hospital & Medical Institute

Ahmedabad, Gujarat, 380054, India

Location

EPIC Hospital

Ahmedabad, Gujarat, 380060, India

Location

Sri Jayadeva Institute of Cardiovascular Sciences & Research

Bangalore, Karnataka, 560069, India

Location

Narayana Institute of Cardiac Sciences

Bangalore, Karnataka, 560099, India

Location

Amrita Institute of Medical Sciences and Research Center

Kochi, Kerala, 682041, India

Location

P.D. Hinduja National Hospital and Medical Research Centre

Mumbai, Maharashtra, 400016, India

Location

The Madras Medical Mission

Chennai, Tamil Nadu, 600037, India

Location

G. Kuppuswamy Memorial Hospital

Coimbatore, Tamil Nadu, 641037, India

Location

CARE Hospitals

Hyderabad, Telangana, 500034, India

Location

Manmohan Cardiothoracic Vascular and Transplant Center

Kathmandu, Nepal

Location

Results Point of Contact

• Title: Jenell Lorenz, Sr. Clinical Research Specialist
• Organization: Medtronic

jenell.m.lorenz@medtronic.com

651-269-4768

Study Officials

• Vinay Rajan, Ph.D

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: September 14, 2017
• Study Start: April 10, 2017
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: February 11, 2025
• Results First Posted: February 11, 2025

Record last verified: 2025-02

Locations

BA (1); IN (10); NE (1)