N/A
N=200
PRESERVE-MITRAL Post-Market Registry
Mitral Valve Disease
Bottom Line
View on ClinicalTrials.gov: NCT03283722 ↗Enrolled (actual)
200
Serious AEs
13.3%
Results posted
Feb 2025
Primary outcome: Primary: Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure — 97.8 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Profile 3D™ and CG Future® annuloplasty system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Surgery
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure |
97.8 | — |
| PRIMARY All Cause Mortality |
6 | — |
| SECONDARY Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months) |
100; 97.5 | — |
| SECONDARY Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline. |
73.4; 84.5; 83.8 | — |
| SECONDARY Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure |
4; 1 | — |
| SECONDARY Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure |
0; 0; 0 | — |
| SECONDARY Stroke at 6 Months and at 12 Months Post Procedure |
2; 0 | — |
| SECONDARY New Onset of Atrial Fibrillation, as Evaluated Through Follow up ECG at Discharge, First Follow up (3-6months) and at Second Follow up (12 Months) |
3.6; 4.8; 4.8 | — |
| SECONDARY Number of Attempts Required for Procedural Success |
177; 3 | — |
| SECONDARY Total Bypass Time During the Implant Procedure |
125.1 | — |
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 months from the day of procedure
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03283722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.