PRESERVE-Mitral Post-Market Registry or Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia.

Prospective REgistry to Study Clinical OutcomeEs of Repair of Mitral ValvEs in South Asia

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/08/009372

Enrollment

200

Registered

2017-08-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure as part of standard care

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with valvular insufficiency and/or stenosis and indicated for the reconstruction and/or remodeling of pathological mitral valves with Profile 3DTM and CG Future annulopasty 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 Authorised 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

Exclusion criteria: 1. Contraindications as per IFU: a. Heavily calcified valves b. Valvular retraction with severely reduced mobility c. 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

Design outcomes

Primary

Measure	Time frame
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products ( Profile 3DTM and CG Future annuloplasty systems) in the approved intended use up to 12 months from the day of procedure.Timepoint: 12 months post procedure	—

Secondary

Measure	Time frame
Characterize the demographics of the patients undergoing mitral valve repair using annuloplasty systems in South Asia, and assess the functional and procedural outcomes of the procedure.Timepoint: Discharge, 3-6 months	—

Countries

Bangladesh, India, Nepal

Contacts

Public ContactVinay Rajan

India Medtronic Pvt. Ltd.

vinay.rajan@medtronic.com02233074700

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026