OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation

NCT ID: NCT03842397

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-30
• Study Completion Date: 2018-11-28

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.

Conditions

Mitral Valve Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implanted Patients

Implantation of Kephalios Device 1

Group Type: EXPERIMENTAL

Kephalios Device 1

Intervention Type: DEVICE

The Kephalios Device 1 is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of the Kephalios Device 1 is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3

Interventions

Kephalios Device 1

The Kephalios Device 1 is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of the Kephalios Device 1 is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kephalios

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin ANDREAS, MBA,PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery

Locations

Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery

Vienna, , Austria

Countries

Austria

Other Identifiers

OPTIMISE

Identifier Type: -

Identifier Source: org_study_id