Improve SCA Bridge Study

Medtronic

Status: Completed

Conditions: Sudden Cardiac Arrest; Acute Myocardial Infarction

Treatments: Behavioral: Non-Referred group; Behavioral: EP referred group

Study type: Observational

Funder types: Industry

Identifiers

NCT03715790

MDT18019

Details and patient eligibility

About

The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute phase (≤14 days post- acute MI) and chronic phase (≥40-90 days post-acute MI).

Full description

To determine how many patients are referred for sudden cardiac death (SCD) risk stratification and management, indicated for implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant, and how many receive such devices within 12 months of experiencing an MI.

Enrollment: 1,491 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 and above (or meet age requirements per local law)
• Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI) ≤ 30 days of study enrollment and have a LVEF <50% measurement ≤ 14 days post-acute MI
• Willing and able to give valid Informed Consent

Exclusion criteria

• Patient has previously received or currently implanted with an ICD or CRT-D
• Patient has any contraindication for ICD/CRT-D
• Patient has a life expectancy of less than 12 months
• Patient who has had an EP referral within the last 12 months
• Any exclusion criteria required by local law (e.g. pregnancy, breast feeding etc.)
• Patient is unable (e.g. mental disorder) or unwilling to be compliant with the responsibilities as specified in the informed consent form.
• Patient is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader

Trial design

1,491 participants in 2 patient groups

EP Referred Group

Description:

Subjects with EF ≤ 40% or meeting one of the referral criteria

Treatment:

Behavioral: EP referred group

Non-Referred Group

Description:

Subjects with 40%\< EF \<50%.

Treatment:

Behavioral: Non-Referred group