ENRAPT-MR Trial: Epicardial Mitral Repair
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Mitre Medical Corp.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Safety - 30 - Day Major Adverse Event Rate
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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)).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has moderate (2+), moderate-to-severe (3+) or severe (4+) ischemic or functional Mitral regurgitation per 2D or 3D echocardiography, symptomatic or asymptomatic
- •Patient is 18 years of age or older
- •Patient is willing and able to sign informed consent form
Exclusion Criteria
- •History of endocarditis or current endocarditis
- •Structural abnormalities of the leaflets and papillary muscles\*
- •Dysfunctional chordae\*
- •Any prior cardiac surgery including but not limited to CABG, Mitral Valve repair surgery, mechanical prosthetic Valve, or ventricular assist device, prior sternotomy\*
- •Ejection fraction \<25%
- •New York Hheart Association (NYHA) class IV
- •MV diameters \> 7cm
- •Myxomatous Mitral regurgitation
- •Renal insufficiency (eGFR \< 30 ml/min)
- •Severely calcified (posterior) Mitral Valve annulus
Outcomes
Primary Outcomes
Safety - 30 - Day Major Adverse Event Rate
Time Frame: 30-Days
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
Secondary Outcomes
- Technical Success - MR Reduction(30-Days, 6 Months, 12 Months)
- Technical Success - Septa-Lateral Reduction(Implantation, 6 Months, 12 Months)
- Technical Success - Coaptation Length Increase(30-Days, 6 Months, 12 Months)
- Technical Success - Improvement in NYHA Classification(6 & 12 Months)