Clinical trial NCT03842397: OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation
Official title: OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation (OPTIMISE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Regurgitation
Keywords: Mitral regurgitation
Mitral valve repair
Mitral annuloplasty
Adjustable annuloplasty
Lead sponsor: Affluent Medical
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The optimal surgical approach in functional mitral regurgitation (MI) was questioned in favour for prosthetic replacement due to the reduced risk of recurrent MI . However, adjustable mitral rings may provide an alternative . In this first-in-man trial, a novel balloon-adjustable mitral-ring was assessed regarding clinical safety and feasibility. 5 patients will be enrolled according to the inclusion/ exclusion criteria and subsequently implanted with the study device. Study visits will be performed preoperatively, perioperatively, at discharge, at 30 days, 3 months and 6 months. Primary outcome parameter will be morbidity and mortality at 30 days following implantation.


Eligibility criteria: Inclusion Criteria:

Patients

1. with symptomatic severe Mitral Regurgitation (Carpentier's classification Type I or II P2) or in asymptomatic subjects with preserved Left Ventricle function and new onset of atrial fibrillation or pulmonary hypertension;
2. with EuroScore II \< 4;
3. with Left Ventricle Ejection Fraction ≥ 55%;
4. with normal coronary angiogram (no significant lesions);
5. in satisfactory condition, based on the physical exam and investigator's experience, with a life expectancy above one year after the intervention;
6. willing to sign the informed consent;
7. willing to undergo all medical follow-up, echocardiography examinations and laboratory tests planned for the clinical investigation.

Exclusion Criteria:

Patients

1. of age \< 18 years;
2. who are pregnant;
3. nursing mothers;
4. who require undergoing MRI examination;
5. involved in any other clinical investigation for drugs or devices;
6. with previous cardiac surgery or diaphragmatic lesion or previous hepatic surgery;
7. needing acute intervention;
8. with active endocarditis (or having had active endocarditis in the last three months);
9. with active myocarditis;
10. with heavily calcified mitral annulus or mitral valve anatomy with a high risk of valve replacement instead of valve repair;
11. needing any cardiac surgery other than mitral repair, tricuspid valve annuloplasty, pacemaker implantation (epicardial), exclusion of left appendage (with device or surgically) and Maze (or PVI) procedure;
12. with severe pulmonary hypertension (systolic pulmonary artery pressure at rest \>65 mmHg);
13. with LV Ejection Fraction \< 55%;
14. with creatinine level \> 2.0 mg/100ml;
15. with echocardiographic measurements predicting SAM (see specific echocardiography protocol);
16. unable to take anticoagulation medications;
17. with a known untreatable allergy to contrast media or nickel;
18. with a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy shorter than 1 year, or for whom the implant of the device produces an unacceptable increase of risk;
19. having had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥ 30 days prior to the planned surgical procedure.
20. unable to understand and sign the ICF in absence of legal protection
21. unable to read and write
22. anticipated ring size very small (26mm) or very large (36mm)

Primary outcomes:
measure: Assessment of the safety of the Kephalios Device 1 in terms of mortality
timeFrame: 30 days after implant
measure: Assessment of the safety of the Kephalios Device 1 in terms of morbidity
timeFrame: 30 days after implant
Secondary outcomes:
measure: Safety in terms of mortality
timeFrame: 3 and 6 months after implant
measure: Safety in terms of morbidity
timeFrame: 3 and 6 months after implant
measure: Effectiveness in terms of increase of mitral leaflets coaptation
timeFrame: in the immediate post-operative phase
measure: Effectiveness in terms of reduction of Mitral Regurgitation
timeFrame: in the immediate post-operative phase
measure: Effectiveness in terms of absence of recurrent Mitral Regurgitation
timeFrame: At hospital discharge or 30 days if subject is still hospitalized, and 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
Study officials:
affiliation: Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
name: Martin ANDREAS, MBA,PhD
role: PRINCIPAL_INVESTIGATOR
References: