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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/08/009372
• Date of registration: 16-08-2017
• Prospective Registration: Yes
• Primary sponsor: Medtronic Plc
• Public title: PRESERVE-Mitral Post-Market Registry or Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia.
• Scientific title: Prospective REgistry to Study Clinical OutcomeEs of Repair of Mitral ValvEs in South Asia
• Date of first enrolment: 11-10-2017
• Target sample size: 200
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18694
• Study type: PMS
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 4

Countries of recruitment

Bangladesh, India, Nepal

Contacts

• Name: Vinay Rajan
• Affiliation: India Medtronic Pvt. Ltd.

• Name: Vinay Rajan
• Affiliation: India Medtronic Pvt. Ltd.

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Intervention1: NIL: NIL
Control Intervention1: NIL: NIL

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

India Medtronic Pvt. Ltd. Solitaire Corporate Park, Bldg No. 12, 4th Floor Andheri Ghatkopar Link Road, Andheri (e) Mumbai, Maharashtra - 400093 India

Secondary Sponsor(s)

India Medtronic Pvt Ltd

Ethics review

Status: Approved
Approval date: 22/07/2017
Contact:

Institutional Ethics Committee, SAL Hospital and Medical Institute

Status: Approved
Approval date: 04/09/2017
Contact:

Institutional Ethics Committee, GKNM

Status: Approved
Approval date: 08/09/2017
Contact:

Institutional Ethics Committee, The Madras Medical Mission

Status: Approved
Approval date: 12/09/2017
Contact:

Institutional Ethics Committee , Care Hospital

Status: Approved
Approval date: 17/12/2017
Contact:

Institutional Ethics Committee of BJ Medical College & Civil Hospital

Status: Approved
Approval date: 28/01/2018
Contact:

National Heart Foundation Hospital & Research Institute

Status: Approved
Approval date: 30/01/2018
Contact:

Institutional Ethics Commitee for Human Research Star Hospitals

Status: Approved
Approval date: 26/02/2018
Contact:

Nepal Health Research Council

Status: Approved
Approval date: 28/02/2018
Contact:

Institutional Ethics Commitee, Hinduja Hospital

Status: Approved
Approval date: 05/03/2018
Contact:

Institutional Ethics Committee Amrita Institute of Medical Sciences and Research Centre

Status: Approved
Approval date: 30/11/2018
Contact:

Sri Jayadeva Institute Ethics Committee

Status: Approved
Approval date: 18/05/2019
Contact:

Narayana Health Medical Ethics Commitee

Status: Approved
Approval date: 08/01/2020
Contact:

Ethics Committee of Shreeji Hopsital

Status: Not Approved
Approval date:
Contact:

Ethic Committee, All India Institute of Medical Sciences