Status:
WITHDRAWN
Ventricular Sling for Heart Failure With Reduced Ejection Fraction
Lead Sponsor:
University of Miami
Conditions:
Heart Failure
Cardiomyopathy, Dilated
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research is to investigate the effect of using this surgical technique in conjunction with bypass surgery to improve heart function and size, as well as decrease the possibility of...
Detailed Description
The Sling is used to draw together the ventricular walls at the base of the papillary muscles. This technique has previously been used in conjunction with mitral valve surgery, and has shown significa...
Eligibility Criteria
Inclusion
- Patients with symptomatic heart failure with reduced ejection fraction and either ischemic or non-ischemic cardiomyopathies, referred for CABG surgery. Suitability for the ventricular sling procedure is determined by the surgeon and or cardiologist, using some or all the criteria described below:
- Left ventricular end diastolic diameter is greater than or equal to 55mm.
- Ejection fraction ≥20% and ≤40%
- FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography at the time of the study approval (via a transthoracic or transesophageal echo).
- End-systolic Interpapillary muscle distance ≥ 20mm
- Cardiomyopathy of ischemic or non-ischemic origins.
- Able to sign informed consent and release of medical information forms, or able to assign a legal representative who can sign on the patient's behalf.
Exclusion
- Any evidence of structural (chordal or leaflet) mitral lesions.
- Planned concomitant intra-operative procedures (except for closure of patent foramen ovale or atrial septal defect or coronary revascularization)
- Planned concomitant intra-operative Maze procedure for symptomatic paroxysmal atrial fibrillation.
- Persistent atrial fibrillation
- Prior mitral valve repair
- Contraindication for cardiopulmonary bypass
- Clinical signs of cardiogenic shock
- ST segment elevation myocardial infarction within 14 days prior to inclusion in this study.
- Congenital heart disease (except PFO or ASD)
- Chronic renal insufficiency defined by Creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac surgery
- Recent history of psychiatric disease that is likely to impair compliance with the study protocol, in the judgement of the investigator
- Pregnancy
Key Trial Info
Start Date :
December 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04475315
Start Date
December 12 2021
End Date
December 1 2027
Last Update
May 11 2022
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