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

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

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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Regurgitation
• Intervention / Treatment: Device: Kephalios Device 1

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Implanted Patients; Implantation of Kephalios Device 1

Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the safety of the Kephalios Device 1 in terms of mortality	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	30 days after implant
Assessment of the safety of the Kephalios Device 1 in terms of morbidity	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	30 days after implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety in terms of mortality	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	3 and 6 months after implant
Safety in terms of morbidity	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	3 and 6 months after implant
Effectiveness in terms of increase of mitral leaflets coaptation	through data objectively measured through echocardiography	in the immediate post-operative phase
Effectiveness in terms of reduction of Mitral Regurgitation	through data objectively measured through echocardiography	in the immediate post-operative phase
Effectiveness in terms of absence of recurrent Mitral Regurgitation	through data objectively measured through echocardiography	At hospital discharge or 30 days if subject is still hospitalized, and 6 months

Collaborators and Investigators

• Sponsor: Kephalios
• Investigators: Principal Investigator: Martin ANDREAS, MBA,PhD, Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2017
• Primary Completion (Actual): July 2, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Mitral annuloplasty; Mitral valve repair; Mitral regurgitation; Adjustable annuloplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: OPTIMISE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No