PRESERVE-Mitral Post-Market Registry or Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia.
- Conditions
- Health Condition 1: null- Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure as part of standard care
- Registration Number
- CTRI/2017/08/009372
- Lead Sponsor
- Medtronic Plc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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