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

Not Applicable

Completed

• Conditions: Mitral Valve Regurgitation
• Interventions: Device: Kephalios Device 1

• Registration Number: NCT03842397
• Lead Sponsor: Kephalios

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-30
• Primary Completion: 2018-07-02
• Study Completion: 2018-11-28
• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implanted Patients	Kephalios Device 1	Implantation of Kephalios Device 1

Primary Outcome Measures

Name	Time	Method
Assessment of the safety of the Kephalios Device 1 in terms of mortality	30 days after implant	Valve-relatedness determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., ... Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082alve-relatedness determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., ... Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082
Assessment of the safety of the Kephalios Device 1 in terms of morbidity	30 days after implant	Morbid events determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., ... Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082

Secondary Outcome Measures

Name	Time	Method
Effectiveness in terms of reduction of Mitral Regurgitation	in the immediate post-operative phase	through data objectively measured through echocardiography
Safety in terms of mortality	3 and 6 months after implant	Valve-relatedness determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., ... Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082
Safety in terms of morbidity	3 and 6 months after implant	Morbid events determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., ... Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082
Effectiveness in terms of absence of recurrent Mitral Regurgitation	At hospital discharge or 30 days if subject is still hospitalized, and 6 months	through data objectively measured through echocardiography
Effectiveness in terms of increase of mitral leaflets coaptation	in the immediate post-operative phase	through data objectively measured through echocardiography

Trial Locations

Locations (1)

Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery; 🇦🇹 Vienna, Austria