Status:
COMPLETED
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation
Lead Sponsor:
Kephalios
Conditions:
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- needing any cardiac surgery other than mitral repair, tricuspid valve annuloplasty, pacemaker implantation (epicardial), exclusion of left appendage (with device or surgically) and Maze (or PVI) procedure;
- 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);
- 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;
- having had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥ 30 days prior to the planned surgical procedure.
- unable to understand and sign the ICF in absence of legal protection
- unable to read and write
- anticipated ring size very small (26mm) or very large (36mm)
Key Trial Info
Start Date :
December 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03842397
Start Date
December 30 2017
End Date
November 28 2018
Last Update
February 26 2021
Active Locations (1)
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1
Medical University of Vienna - Department of Surgery, Division of Cardiac Surgery
Vienna, Austria, 1090