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

NCT03842397 | Completed

• 1 other identifier: OPTIMISE
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The optimal surgical approach in functional mitral regurgitation (MI) was questioned in favour for prosthetic replacement due to the reduced risk of recurrent MI . However, adjustable mitral rings may provide an alternative . In this first-in-man trial, a novel balloon-adjustable mitral-ring was assessed regarding clinical safety and feasibility. 5 patients will be enrolled according to the inclusion/ exclusion criteria and subsequently implanted with the study device. Study visits will be performed preoperatively, perioperatively, at discharge, at 30 days, 3 months and 6 months. Primary outcome parameter will be morbidity and mortality at 30 days following implantation.

Conditions

Mitral Valve Regurgitation

Keywords

Mitral regurgitation; Mitral valve repair; Mitral annuloplasty; Adjustable annuloplasty

Outcome Measures

Primary Outcomes (2)

• Assessment of the safety of the Kephalios Device 1 in terms of mortality

  Valve-relatedness determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082alve-relatedness determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082

  30 days after implant

• Assessment of the safety of the Kephalios Device 1 in terms of morbidity

  Morbid events determined according to the STS/AATS/EACTS report - Akins, C. W., Miller, D. C., Turina, M. I., Kouchoukos, N. T., Blackstone, E. H., Grunkemeier, G. L., … Lytle, B. W. (2008). Guidelines for Reporting Mortality and Morbidity After Cardiac Valve Interventions. The Annals of Thoracic Surgery, 85(4), 1490-1495. https://doi.org/10.1016/j.athoracsur.2007.12.082

  30 days after implant

Secondary Outcomes (5)

• Safety in terms of mortality

  3 and 6 months after implant

• Safety in terms of morbidity

  3 and 6 months after implant

• Effectiveness in terms of increase of mitral leaflets coaptation

  in the immediate post-operative phase

• Effectiveness in terms of reduction of Mitral Regurgitation

  in the immediate post-operative phase

• Effectiveness in terms of absence of recurrent Mitral Regurgitation

  At hospital discharge or 30 days if subject is still hospitalized, and 6 months

Study Arms (1)

Implanted Patients

EXPERIMENTAL

Implantation of Kephalios Device 1

Device: Kephalios Device 1

Interventions

Kephalios Device 1 DEVICE

The Kephalios Device 1 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 the Kephalios Device 1 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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients
• with symptomatic severe Mitral Regurgitation (Carpentier's classification Type I or II P2) or in asymptomatic subjects with preserved Left Ventricle function and new onset of atrial fibrillation or pulmonary hypertension;
• with EuroScore II \< 4;
• with Left Ventricle Ejection Fraction ≥ 55%;
• with normal coronary angiogram (no significant lesions);
• in satisfactory condition, based on the physical exam and investigator's experience, with a life expectancy above one year after the intervention;
• willing to sign the informed consent;
• willing to undergo all medical follow-up, echocardiography examinations and laboratory tests planned for the clinical investigation.

You may not qualify if:

• Patients
• of age \< 18 years;
• who are pregnant;
• nursing mothers;
• who require undergoing MRI examination;
• involved in any other clinical investigation for drugs or devices;
• with previous cardiac surgery or diaphragmatic lesion or previous hepatic surgery;
• needing acute intervention;
• with active endocarditis (or having had active endocarditis in the last three months);
• with active myocarditis;
• with heavily calcified mitral annulus or mitral valve anatomy with a high risk of valve replacement instead of valve repair;
• with severe pulmonary hypertension (systolic pulmonary artery pressure at rest \>65 mmHg);
• with LV Ejection Fraction \< 55%;
• with creatinine level \> 2.0 mg/100ml;
• with echocardiographic measurements predicting SAM (see specific echocardiography protocol);

Sponsors & Collaborators

• Kephalios: lead

Study Sites (1)

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

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Martin ANDREAS, MBA,PhD

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

  PRINCIPAL INVESTIGATOR

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: February 7, 2019
• First Posted: February 15, 2019
• Study Start: December 30, 2017
• Primary Completion: July 2, 2018
• Study Completion: November 28, 2018
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

AU (1)