Mitral Touch System This device is designed to epicardially reshape the mitral valve annulus without the need for cardiopulmonary bypass (CPB) and open heart access (atriotomy), in patients with left ventricular dilation and ischemic or functional MR (mitral regurgitation (MR)).
Mitre Medical has developed an epicardial mitral annuloplasty device that can be implanted concomitant during planned coronary artery bypass surgery to help treat the MR patients. The Mitral Touch is designed to restore the S-L dimension and has the advantage of being placed without stopping the heart and placing the patient on a bypass pump.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The study population for this study will be comprised of patients who are to undergo cardiac surgery with a sternotomy (e.g. CABG) and who present moderate to severe ischemic or functional MR. In order to be considered eligible for the study, each patient must meet the conditions listed in the inclusion and none of the exclusion criteria.
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania
RECRUITINGSafety - 30 - Day Major Adverse Event Rate
30 - Day Major Adverse Event Rate All-cause mortality Stroke Life-threatening bleeding (MVARC scale) Major vascular complications Major cardiac structural complications Stage 2 or 3 acute kidney injury (includes new dialysis) Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for \>48 h Emergency surgery or re-intervention related to the device or access procedure
Time frame: 30-Days
Technical Success - MR Reduction
MR assessment of MR Grade by TTE compared to baseline
Time frame: 30-Days, 6 Months, 12 Months
Technical Success - Coaptation Length Increase
An increase of coaptation length compared to baseline
Time frame: 30-Days, 6 Months, 12 Months
Technical Success - Septa-Lateral Reduction
Target of 15%-30% Reduction when compared to baseline
Time frame: Implantation, 6 Months, 12 Months
Technical Success - Improvement in NYHA Classification
Reduction in NYHA Classification compared to baseline
Time frame: 6 & 12 Months
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