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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Regurgitation
• Intervention / Treatment: Device: Kalios Implant

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michel Finance; Phone Number: +33 6 18 39 93 93; Email: michel.finance@affluentmedical.com

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
• Germany
  • Leipzig, Germany
    • Recruiting
    • University Clinic of Cardiac Surgery, Heart Center
    • Contact: Martin Misfeld
  • Passau, Germany
    • Recruiting
    • Klinikum Passau
    • Contact: Markus Czesla
• Italy
  • Cotignola, Italy
    • Recruiting
    • Maria Cecilia Hospital Cotignola
    • Contact: Alberto Albertini
  • Florence, Italy, 50134
    • Recruiting
    • Careggi Hospital
    • Contact: Pierluigi Stefano
  • Milan, Italy
    • Not yet recruiting
    • Humanitas Research Hospital
    • Contact: Lucia Torraca
  • Milan, Italy
    • Not yet recruiting
    • Ospedale Luigi Sacco
    • Contact: Carlo Antona
  • Palermo, Italy
    • Recruiting
    • Maria Eleonora Hospital Palermo
    • Contact: Khalil Fattouch
• Switzerland
  • Lausanne, Switzerland
    • Not yet recruiting
    • Centre Hospitalier Universitaire Vaudois
    • Contact: Matthias Kirsch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the effectiveness of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s)	Absence of Mitral Regurgitation of grade > 2 (through echographic assessment)	At 1 year
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)	Incidence of Major Adverse Cardiac Events (MACE)	At 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Absence of Mitral Regurgitation of grade > 2 (through echographic assessment)	at 1, 3 6, 24, 36, 48 and 60 months
Assessment of the adjustment functionality of the device	Assessment of mitral leaflets coaptation (through echographic assessment)	immediately after annuloplasty, at 1, 3, 6, 12, 24, 36, 48 and 60 months
Assessment of the adjustment functionality of the device	Assessment of the increase of mitral leaflets coaptation length (through echographic assessment)	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 safety of KALIOS for the surgical treatment of Mitral Regurgitation with optional intra-operative and/or post-operative adjustment(s)at each follow up	Incidence of Major Adverse Cardiac Events (MACE)	at 1, 3, 6, 24, 36, 48 and 60 months

Collaborators and Investigators

• Sponsor: Kephalios

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 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 Regurgitation; Mitral annuloplasty; Mitral valve repair; Adjustable annuloplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: OPTIMISE II

Drug and device information, study documents

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