Patient and Physician Survey Determinants of Appropriate ICD Utilization

NCT ID: NCT01514773

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 452 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-08-30

Brief Summary

To better understand the reasons for underutilization of defibrillator therapy in selected populations, the investigators propose a study to assess heart failure patient knowledge and attitudes toward device therapy. By carefully studying populations of patients with systolic heart failure, the investigators aim to identify the underlying reasons for implantable cardioverter defibrillators (ICD) non-utilization in patients with symptomatic systolic heart failure.

Detailed Description

Several multi-center randomized trials have demonstrated the benefit of implantable cardioverter defibrillators (ICDs) for the primary prevention of sudden cardiac death among patients with ischemic and nonischemic cardiomyopathy. Guideline documents for the treatment of heart failure have recommended defibrillator placement for patients with symptomatic heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Despite these recommendations, observational studies have documented low ICD utilization among patients with heart failure. Recent studies have demonstrated patient specific characteristics that are associated with low ICD utilization (advanced age, female gender, black race, heart failure etiology, uninsured patients and patients cared for by general practitioners). Whether patient knowledge or attitudes regarding defibrillator therapy influence the rate of defibrillator placement is unknown. By carefully surveying populations of patients with systolic heart failure, we aim to further the understanding of the patient factors that determine why an ICD may or may not be used in the appropriate clinical setting. Additionally, 150 physicians will be enrolled into the study for the purpose of measuring attitudes and beliefs regarding defibrillator treatment for the physicians providing care to the patients in the study.

Conditions

Heart Failure, Systolic

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

ICD placement

Those subjects who have an ICD.

No interventions assigned to this group

No ICD placement

Those subjects who have not had an ICD placed.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old
• Left ventricular ejection fraction ≤ 35%
• Previous diagnosis of heart failure with current NYHA Class II-III symptoms
• Established UMHS patient with at least two outpatient visits in the past two years to either Primary Care or Cardiology, OR, at least one inpatient admission in the past two years along with at least one outpatient visit within the past 13 months to Primary Care or Cardiology

Exclusion Criteria

• Patients having undergone heart transplantation
• Patients having undergone placement of a left ventricular assist device
• Patients with congenital heart disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Todd M Koelling, MD

OTHER

Sponsor Role: lead

Responsible Party

Todd M Koelling, MD

Associate Professor, Director Heart Failure Program

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Todd M Koelling, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Health System

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00050147

Identifier Type: -

Identifier Source: org_study_id