NCT03908983

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
4 countries

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

April 5, 2019

Last Update Submit

February 25, 2021

Conditions

Mitral Valve Regurgitation

Keywords

Mitral RegurgitationMitral valve repairMitral annuloplastyAdjustable annuloplasty

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

    at 1, 3 6, 24, 36, 48 and 60 months

  • Assessment of the adjustment functionality of the device

    immediately after annuloplasty, at 1, 3, 6, 12, 24, 36, 48 and 60 months

  • Assessment of the adjustment functionality of the device

    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

    at 1, 3, 6, 24, 36, 48 and 60 months

Study Arms (1)

Implanted Patients

EXPERIMENTAL

Implantation of Kalios Device

Device: Kalios Implant

Interventions

Kalios ImplantDEVICE

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

Implanted Patients

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 :
  • 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%
  • 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
  • with LVEF ≥ 30%
  • in satisfactory condition, based on the physical examination and investigator's experience, with a life expectancy above one year after the intervention
  • willing to sign the informed consent;
  • able and willing to comply with all clinical investigation requirements, including the required study follow-up visits

You may not qualify if:

  • Patients will be excluded if ANY of the following conditions are present:
  • of age \< 21 years;
  • with echocardiographic measurements predicting SAM
  • LVEDD \< 45 mm
  • C-Sd \< 25mm (distance from the septum to the mitral valve coaptation point)
  • Basal-IVDd \> 15 mm
  • aorto-mitral angle \< 120°
  • pre-repair posterior leaflet height \> 15 mm
  • with cardiogenic shock;
  • with active endocarditis (or having had active endocarditis in the last three months);
  • with active myocarditis;
  • with heavily calcified mitral annulus;
  • with mitral stenosis;
  • unable to take anticoagulation medications;
  • with a known untreatable allergy to contrast media or nickel;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery

Vienna, Austria

RECRUITING

University Clinic of Cardiac Surgery, Heart Center

Leipzig, Germany

RECRUITING

Klinikum Passau

Passau, Germany

RECRUITING

Maria Cecilia Hospital Cotignola

Cotignola, Italy

RECRUITING

Careggi Hospital

Florence, 50134, Italy

RECRUITING

Humanitas Research Hospital

Milan, Italy

NOT YET RECRUITING

Ospedale Luigi Sacco

Milan, Italy

NOT YET RECRUITING

Maria Eleonora Hospital Palermo

Palermo, Italy

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Michel Finance

CONTACT

+33 6 18 39 93 93michel.finance@affluentmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 9, 2019

Study Start

November 20, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2025

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

CH(1)DE(2)AU(1)IT(5)