Mitral Valve RegurgitationNCT03908983
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation
A study testing Kalios Implant in people with Mitral Valve Regurgitation, run by Kephalios at 9 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Kalios Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 20 Nov 2019to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet ALL the following inclusion criteria :
- 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%
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- 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
- 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
- willing to sign the informed consent;
- able and willing to comply with all clinical investigation requirements, including the required study follow-up visits
Who cannot join
- 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
Show all 22Show fewer
- 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;
- 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;
- with contraindication to transoesophageal echocardiography;
- with contraindication to cardiopulmonary bypass;
- who are pregnant or breast-feeding women;
- involved in any other clinical investigation for drugs or devices;
- unable to understand and sign the ICF in absence of legal protection;
- unable to read and write;
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Italy5 sites, 5 recruiting
- Recruiting
Maria Cecilia Hospital Cotignola
Cotignola
Alberto Albertini
- Recruiting
Careggi Hospital
Florence, 50134
Pierluigi Stefano
- Not yet recruiting
Humanitas Research Hospital
Milan
Lucia Torraca
- Not yet recruiting
Ospedale Luigi Sacco
Milan
Carlo Antona
- Recruiting
Maria Eleonora Hospital Palermo
Palermo
Khalil Fattouch
Germany2 sites, 2 recruiting
- Recruiting
University Clinic of Cardiac Surgery, Heart Center
Leipzig
Martin Misfeld
- Recruiting
Klinikum Passau
Passau
Markus Czesla
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
Vienna
Martin Andreas
Switzerland1 site, 1 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne
Matthias Kirsch
About this study
Official title: 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.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Kalios Implant
- Keywords
- Mitral Regurgitation, Mitral valve repair, Mitral annuloplasty, Adjustable annuloplasty
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Implanted Patients | Experimental | Implantation of Kalios Device Receives: Device: Kalios Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Absence of Mitral Regurgitation of grade > 2 (through echographic assessment)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at 1, 3, 6, 24, 36, 48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start20 Nov 2019
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kephalios
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908983
- Sponsor's protocol ID
- OPTIMISE II
- Status last verified
- Feb 2021
- First submitted
- 5 Apr 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation (OPTIMISE II)
- ClinicalTrials.gov ID
- NCT03908983
- Acronym / sponsor ID
- OPTIMISE II
- Conditions
- Mitral Valve Regurgitation
- Keywords
- Mitral Regurgitation, Mitral valve repair, Mitral annuloplasty, Adjustable annuloplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KephaliosIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted Patients | Experimental | Device: Kalios ImplantImplantation of Kalios Device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must meet ALL the following inclusion criteria :
- 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 :
- 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
- 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
Key exclusion criteria (22 listed)
- Patients will be excluded if ANY of the following conditions are present:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kalios ImplantKALIOS 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 | Device | Implanted Patients |
Primary outcome
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)
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)
4 secondary outcomes
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
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 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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kalios Implant in people with Mitral Valve Regurgitation, run by Kephalios at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Finance (+33 6 18 39 93 93, michel.finance@affluentmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.