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

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ClinicalTrials.gov Identifier: NCT03908983
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Affluent Medical ( Kephalios )

Study Description
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Brief Summary:

KALIOS is indicated for the surgical treatment of mitral regurgitation by mitral valve repair.It is intended for mitral valve repair using conventional open heart or minimally invasive techniques.

The KALIOS device 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 KALIOS 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

The primary objective of this clinical investigation is to assess the safety and effectiveness of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s) The secondary objectives are to investigate the effects of KALIOS for the surgical treatment of Mitral Regurgitation on cardiac function and on patient functional status This clinical trial is prospective, non-randomized, single arm, multicentric & international. Up to 100 patients are expected to be enrolled to obtain 62 evaluable patients at one year,presenting with primary (degenerative) or secondary (functional) mitral valve regurgitation and who are candidate to a mitral valve repair.


Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: Kalios Implant Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation (OPTIMISE II)
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Implanted Patients
Implantation of Kalios Device
 Device: Kalios Implant
KALIOS 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 KALIOS 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


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the effectiveness of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s) [ Time Frame: At 1 year ]
    Absence of Mitral Regurgitation of grade > 2 (through echographic assessment)

  2. Assessment of the safety of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s)Regurgitation with optional intra-operative and/or post-operative adjustment(s) [ Time Frame: At 1 year ]
    Incidence of Major Adverse Cardiac Events (MACE)


Secondary Outcome Measures :
  1. Assessment of the effectiveness of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s) at each follow up [ Time Frame: at 1, 3 6, 24, 36, 48 and 60 months ]
    Absence of Mitral Regurgitation of grade > 2 (through echographic assessment)

  2. Assessment of the adjustment functionality of the device [ Time Frame: immediately after annuloplasty, at 1, 3, 6, 12, 24, 36, 48 and 60 months ]
    Assessment of mitral leaflets coaptation (through echographic assessment)

  3. Assessment of the adjustment functionality of the device [ Time Frame: after any optional adjustment(s) performed immediately after annuloplasty, or following follow up visits at 1, 3, 6, 12, 24, 36, 48 and 60 months ]
    Assessment of the increase of mitral leaflets coaptation length (through echographic assessment)

  4. Assessment of the safety of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s)at each follow up [ Time Frame: at 1, 3, 6, 24, 36, 48 and 60 months ]
    Incidence of Major Adverse Cardiac Events (MACE)


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients must meet ALL the following inclusion criteria :

  1. with primary or secondary mitral regurgitation recorded by TTE and confirmed during TEE where surgery for mitral valve repair is required with indications consistent with AHA/ACC and ESC/EACTS guidelines :

    1. primary (degenerative) : severe MR grade parameters (R Vol and EROA measured by PISA methods):

      • EROA regurgitant >60 ml and
      • Vena contracta width > 7mm and
      • Regurgitant fraction >50%
    2. Secondary (functional) : severe MR (EROA ≥30 mm²; R Vol > 30ml) may differ from the primary MR and are based on the prognostic value of these thresholds to predict the poor outcome, or for patients undergoing CABG
  2. with LVEF ≥ 30%
  3. in satisfactory condition, based on the physical examination and investigator's experience, with a life expectancy above one year after the intervention
  4. with or without concomitant procedures as: CABG, other valve repair/replacement, pacemaker implantation, exclusion of left appendage (with device or surgically) and Maze (or PVI) procedure
  5. willing to sign the informed consent;
  6. able and willing to comply with all clinical investigation requirements, including the required study follow-up visits

Exclusion Criteria:

  • Patients will be excluded if ANY of the following conditions are present:

    1. of age < 21 years;

    2. with echocardiographic measurements predicting SAM

      1. LVEDD < 45 mm
      2. C-Sd < 25mm (distance from the septum to the mitral valve coaptation point)
      3. Basal-IVDd > 15 mm
      4. aorto-mitral angle < 120°
      5. pre-repair posterior leaflet height > 15 mm
    3. with cardiogenic shock;
    4. with active endocarditis (or having had active endocarditis in the last three months);
    5. with active myocarditis;
    6. with heavily calcified mitral annulus;
    7. with mitral stenosis;
    8. unable to take anticoagulation medications;
    9. with a known untreatable allergy to contrast media or nickel;
    10. 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;
    11. with contraindication to transoesophageal echocardiography;
    12. with contraindication to cardiopulmonary bypass;
    13. who are pregnant or breast-feeding women;
    14. involved in any other clinical investigation for drugs or devices;
    15. unable to understand and sign the ICF in absence of legal protection;
    16. unable to read and write;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908983


Contacts
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Contact: Michel Finance +33 6 18 39 93 93 michel.finance@affluentmedical.com

Locations
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Austria
Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery Recruiting
Vienna, Austria
Contact: Martin Andreas         
Germany
University Clinic of Cardiac Surgery, Heart Center Recruiting
Leipzig, Germany
Contact: Martin Misfeld         
Klinikum Passau Recruiting
Passau, Germany
Contact: Markus Czesla         
Italy
Maria Cecilia Hospital Cotignola Recruiting
Cotignola, Italy
Contact: Alberto Albertini         
Careggi Hospital Recruiting
Florence, Italy, 50134
Contact: Pierluigi Stefano         
Humanitas Research Hospital Not yet recruiting
Milan, Italy
Contact: Lucia Torraca         
Ospedale Luigi Sacco Not yet recruiting
Milan, Italy
Contact: Carlo Antona         
Maria Eleonora Hospital Palermo Recruiting
Palermo, Italy
Contact: Khalil Fattouch         
Switzerland
Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Switzerland
Contact: Matthias Kirsch         
Sponsors and Collaborators
Kephalios
More Information
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Responsible Party: Kephalios
ClinicalTrials.gov Identifier: NCT03908983    
Other Study ID Numbers: OPTIMISE II
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Affluent Medical ( Kephalios ):
Mitral Regurgitation
Mitral valve repair
Mitral annuloplasty
Adjustable annuloplasty
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases