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

Mitral Valve Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03908983
• Other study ID #: OPTIMISE II
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2021
• Source: Affluent Medical
• Contact: Michel Finance
• Phone: +33 6 18 39 93 93
• Email: michel.finance[@]affluentmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery	Vienna
Germany	University Clinic of Cardiac Surgery, Heart Center	Leipzig
Germany	Klinikum Passau	Passau
Italy	Maria Cecilia Hospital Cotignola	Cotignola
Italy	Careggi Hospital	Florence
Italy	Humanitas Research Hospital	Milan
Italy	Ospedale Luigi Sacco	Milan
Italy	Maria Eleonora Hospital Palermo	Palermo
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Kephalios

Countries where clinical trial is conducted

Austria,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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