Surgical treatment for mitral valve regurgitation using an adjustable device
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation (OPTIMISE II)
This study is testing a new adjustable device for heart surgery to see if it can safely fix mitral valve regurgitation and improve patients' heart function and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Affluent Medical Industry-sponsored |
| Locations | 9 sites (Vienna and 8 other locations) |
| Trial ID | NCT03908983 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the safety and effectiveness of the KALIOS device, an adjustable annuloplasty ring, for treating mitral valve regurgitation through surgical repair. The device allows for precise adjustments to the mitral valve's shape and size during or after surgery using a specialized catheter. The study aims to assess not only the immediate outcomes of the surgical intervention but also the long-term effects on cardiac function and patient quality of life. Patients with severe mitral regurgitation, either primary or secondary, will be included based on specific clinical criteria.
Who should consider this trial
Good fit: Ideal candidates are patients with severe mitral regurgitation requiring surgical intervention and a left ventricular ejection fraction of 30% or greater.
Not a fit: Patients with mild mitral regurgitation or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and patient recovery for those with mitral valve regurgitation.
How similar studies have performed: Other studies have shown promise with similar adjustable annuloplasty techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Vienna and 8 other locations
- 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, 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)
Study contacts
- Study coordinator: Michel Finance
- Email: michel.finance@affluentmedical.com
- Phone: +33 6 18 39 93 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.