Status:
COMPLETED
PRESERVE-MITRAL Post-Market Registry
Lead Sponsor:
Medtronic Cardiac Surgery
Conditions:
Mitral Valve Disease
Eligibility:
All Genders
18-99 years
Brief Summary
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 mo...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- Indications and contraindications provided in the product Instructions for Use
- Subject is 18 years of age or older
- 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
- Contraindications as per instructions-for-use (IFU):
- Heavily calcified valves
- Valvular retraction with severely reduced mobility
- Active bacterial endocarditis
- Aortic valve replacement as concomitant procedure
- Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints
Key Trial Info
Start Date :
April 10 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 10 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03283722
Start Date
April 10 2017
End Date
February 10 2021
Last Update
February 11 2025
Active Locations (12)
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1
National Heart Foundation Hospital & Research Institute
Dhaka, Bangladesh, 1216
2
U. N. Mehta Institute of Cardiology and Research Centre
Ahmedabad, Gujarat, India, 380016
3
SAL Hospital & Medical Institute
Ahmedabad, Gujarat, India, 380054
4
EPIC Hospital
Ahmedabad, Gujarat, India, 380060