E-pot Study: EnSite & Pressure- Volume in Cardiac Resynchronization Therapy, a multicenter, prospective, feasability, non-randomized pilot study

Completed

• Conditions: Cardiomyopathy; Heart Failure; 10019280

• Registration Number: NL-OMON32196
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

• CRT-D conventional indication
• QRS width > 120 ms
• Left Ventricular Ejection Fraction (LVEF) < 35%.
• Left Bundle Branch Block (LBBB)
• MI documented by echo or MRI
• Cardiomyopathy stable for the last Month (or longer)
• Pharmacological treatment unchanged during the 3 last Months (or longer)
• Heart failure NYHA class II & III

Exclusion Criteria

• History of chronic AF
• MI within the last 3 Months
• Previous pacemaker or ICD implanted
• Claudication intermittens or other significant arterial vein issues in the aortic-iliac route
• Moderate to severe aortic valve stenosis or indication for valve surgery or mechanical aortic valve replacement or thrombus in Left Ventricle
• Age <18 years or > 80 years
• Heart failure NYHA class IV
• Serious comorbidity such as cancer, with a likelihood of death during the study
• Unwilling or unable to sign the consent form for participation
• Females of childbearing age not using medically prescribed contraceptives

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified