Assessment of Appropriate ICD Implantation for Primary Prevention of Sudden Cardiac Death

NCT00926159 | Completed

• 1 other identifier: Version # 3, December 4, 2009
• Study Type: observational
• Target: 549
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prophylactic implant of an ICD (implantable cardioverter defibrillator) for prevention of sudden cardiac death from a life-threatening heart rhythm abnormality is a standard recommendation for patients with ejection fractions (EFs) of 35% or less. The main purpose of the trial is to determine why patients who are receiving care at a community-based cardiology program and are known to have a low ejection fraction (EF) measurement of 35% or less per echocardiogram and/or cardiac nuclear scan testing are not being approached for ICD (implantable cardioverter defibrillator) implant. Additionally, other secondary purposes of the trial are: 1) to determine if these patients are or are not receiving recommendation from their provider to undergo prophylactic ICD implant 2) identify the reasons providers are not recommending ICD implant for their patients with reduced EFs 3) determine reasons patients recommended for ICD implant by their provider elect not to have the implant.

Conditions

Cardiomyopathies

Keywords

Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

• Minnesota Heart Clinic Provider progress note from the first office visit after the cardiac echocardiogram or nuclear scan that qualified the patient for inclusion in the trial will be reviewed for documentation of discussion regarding ICD implant.

  First scheduled office visit with a Minnesota Heart Clinic Provider scheduled and conducted after the study qualifying cardiac echocardiogram or cardiac nuclear scan.

Secondary Outcomes (1)

• A questionnaire will be issued/reviewed after completed by Providers to obtain reason(s) for not recommending ICD implant.

  Questionnaire will be issued after review of progress note identifies no documentation regarding possible ICD implant.

Study Arms (1)

ICD eligible

Patients with Ejection Fraction (EF) of 35% or less as determined by cardiac echocardiogram or cardiac nuclear scan.

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

Minnesota Heart Clinic Patients with an ejection fraction of 35% or less as identified from cardiac echocardiogram and/or cardiac nuclear scan.

You may qualify if:

• Age 18 years or older
• Ejection fraction of 35% or less by echocardiogram and/or cardiac nuclear scan

You may not qualify if:

• Age less than 18 years
• Patients currently enrolled in a clinical trial that would be impacted by receipt of an ICD
• Pregnant women

Sponsors & Collaborators

• University of Minnesota Physicians Heart at Fairview: lead
• Boston Scientific Corporation: collaborator

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Huagui Li, MD, PhD

  University of Minnesota Physicians, Minnesota Heart Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 23, 2009
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 4, 2011

Record last verified: 2011-01