Patient and Physician Survey Determinants of Appropriate ICD Utilization

NCT01514773 | Completed

• 1 other identifier: HUM00050147
• Study Type: observational
• Target: 452
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Systolic

Keywords

left ventricular systolic dysfunction; implantable cardioverter defibrillator; systolic heart failure; congestive heart failure; Ischemic cardiomyopathy; Nonischemic cardiomyopathy; ICD; ICD utilization; ICD implantation; defibrillator; defibrillator therapy; sudden cardiac death

Outcome Measures

Primary Outcomes (1)

• Patient Determinants of Appropriate ICD Utilization

  Specifically, we will assess patients for knowledge deficits regarding the clinical effects of ICD therapy. We will assess patients for their opinions regarding their risk of death, and whether they are willing to trade time to avoid discomfort of their illness or ICD shocks. We will ask patients about their thoughts about financial concerns regarding ICD therapy and their trust in technology, their physician and the medical system. We will also ask patients about their opinions regarding cosmetic issues created by ICD placement.

  1 year

Secondary Outcomes (1)

• Physician Determinants of Appropriate ICD Utilization

  1 year

Study Arms (2)

ICD placement

Those subjects who have an ICD.

No ICD placement

Those subjects who have not had an ICD placed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University of Michigan Health System Ambulatory Heart Failure Registry

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Todd M Koelling, MD: lead
• Medtronic: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Ventricular Dysfunction, Left; Heart Failure; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Todd M Koelling, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Director Heart Failure Program

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 23, 2012
• Study Start: August 1, 2011
• Primary Completion: August 30, 2013
• Study Completion: August 30, 2013
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

US (1)