PRESERVE-MITRAL Post-Market Registry

Medtronic Cardiac Surgery200 enrolled

Overview

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

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

200

Conditions

Mitral Valve Disease

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (12)

National Heart Foundation Hospital & Research Institute

Dhaka, Bangladesh

U. N. Mehta Institute of Cardiology and Research Centre

Ahmedabad, Gujarat, India

SAL Hospital & Medical Institute

Ahmedabad, Gujarat, India

Outcomes

Primary Outcomes

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.

Time frame: 12 months

All Cause Mortality

All deaths occurring from any cause 12-months post procedure

Time frame: 12 months

Secondary Outcomes

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

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.

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.

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

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)

Data from ClinicalTrials.gov

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