Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention

Launched by JOHNS HOPKINS UNIVERSITY · Aug 12, 2008

Keywords

ClinConnect Summary

**Clinical Trial Summary: Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention**

This clinical trial is studying how certain heart problems can help identify patients at high risk of sudden cardiac death (SCD), which is when the heart unexpectedly stops beating. The researchers believe that understanding the interaction between structural issues (like heart shape or size) and functional problems (like how well the heart is working) can help find people who might benefit most from an internal defibrillator (ICD). An ICD is a device that helps keep the heart beating normally and can prevent sudden death in people with serious heart conditions.

To participate in this study, you may be eligible if you are between the ages of 65 and 74, have a history of heart attack at least four weeks ago, and have been diagnosed with certain heart conditions that affect how well your heart pumps (with a specific measure called ejection fraction of 35% or less). Participants will receive regular check-ups and monitoring to help researchers learn more about the biological factors that increase the risk of SCD. Importantly, the study aims to develop simple tests that can help predict who is at higher risk, potentially leading to better care for those who need it most. If you decide to join, you will be helping to advance our understanding of heart health and improve treatment options for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • History of acute MI at least 4 weeks old
• • Non-ischemic LV dysfunction for at least 9 months
• • Who have an ejection fraction (EF) \< or = to 35%
• • Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment.
• • Who have primary prevention implants.
• Exclusion Criteria:
• • ICD generator replacement for secondary prevention
• • Inability or unwillingness to provide valid informed consent
• • New York Heart Association Class IV heart failure
• • Patients with pre-existing Class 1 indications for pacemaker therapy.