PRESERVE-MITRAL Post-Market Registry

Medtronic

Status: Completed

Conditions: Mitral Valve Disease

Treatments: Device: Profile 3D™ and CG Future® annuloplasty system

Study type: Observational

Funder types: Industry

Identifiers

NCT03283722

MDT16016SUR002

Details and patient eligibility

About

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

Full 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.)

Enrollment: 200 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design