Off-pump left ventricle reconstruction using the Revivent Myocardial Anchoring System in patients with severe ischemic cardiomyopathy.

Completed

• Conditions: 10019280; 10007593; Ischaemic cardiomyopathy; ischaemic heart failure

• Registration Number: NL-OMON44507
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

The following criteria will be applied for inclusion:;- > 18 years of age
- Able to provide written informed consent
- Medical history of antero-septal myocardial infarction with a discreet akinetic/dyskinetic scar located in the antero-septal or apical (may extend laterally) regions of the LV
- Dilated left ventricle with or without aneurysm
- Left ventricular end-systolic volume index (LVESVI) * 60ml/m2
- Left ventricular ejection fraction (LVEF) * 40%
- Symptomatic cardiac dysfunction causing heart failure: NYHA class * II
- Maintenance on stable medical therapy in accordance with prevailing heart failureguidelines
- Mitral valve regurgitation * 1
- With or without cardiac device (ICD/CRT)

Exclusion Criteria

Patients are not eligible for the study if they meet the following criteria: ;- Unable or unwilling to provide written informed consent
- * 18 years of age
- Pregnancy or claustrophobia
- Known concomitant disease with a life expectancy of <1 year
- Calcified ventricular wall in the area of intended scar exclusion
- Thrombus or mass in the left atrium or ventricle
- CRT device placement * 60 days prior to surgery
- Thin walled, paradoxically moving septal scar that would preclude successful support of the anchor pairs
- Significant diastolic dysfunction, defined as a pseudo-normal Doppler filling pattern with E/A ratio>2
- Intolerance or unwillingness to take Acenocoumarol
- Functioning pacemaker leads in antero-apical RV, which would interfere with anchor placement
- Pulmonary arterial pressure > 60 mm Hg
- Myocardial infarction within 90 days prior to surgery
- Chronic renal failure with a serum creatinine > 250 µmol/l.

Study & Design

• Study Type: Interventional
• Study Design: Not specified