Assessment of Appropriate ICD Implantation for Primary Prevention of Sudden Cardiac Death
|ClinicalTrials.gov Identifier: NCT00926159|
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : August 4, 2011
|Condition or disease|
The implantable cardioverter defibrillator (ICD) for patients at high risk of sudden cardiac death (primary prevention) has become an accepted therapy after multiple randomized trials demonstrated the benefit consistently. After years of extensive evaluation of the trial data, Center for Medicare and Medicaid Services(CMS) has approved the national registry that is endorsed by the American College of Cardiology and Heart Rhythm Society. Thus, ICD implantation for primary prevention of sudden cardiac death is one of the most intensively evaluated, strictly regulated and closely monitored therapies.
Since the approval of expanded coverage for primary prevention by CMS along with the requirement for registry participation in early 2005, the ICD implant volume did not show an apparent increase as expected by many. Instead, a flat growth of ICD sales has been observed over the last 2 years. Several explanations have been offered by various sources. Some attribute the slow growth to the loss of confidence among the referring physicians, patients, and family members as the result of the multiple industry recalls. Others claim that only a small portion of the eligible candidates receive ICD therapy because of poor awareness of the ICD benefit among the referring physicians and the public (the Cambridge Heart Commercial). However, the Medtronic campaign to promote public awareness has had little impact on the volume of ICD implants. Another group of people suspect that the cardiologists have not paid enough attention to the patients' candidacy for ICD therapy because they tend to focus on the patients' ongoing symptoms not proactive prevention. Thus,an active screening program may identify a significant number of patients who will benefit from ICD therapy. However, there has been no comprehensive study that has evaluated the impact of active screening on the ICD implant volume, the percentage of eligible ICD patients without ICDs and the reasons for not receiving ICDs.
Majority of ICD implants in the United States are currently performed in the community-based cardiology programs. Thus a proactive program to identify ICD candidates in a community-based program may provide a good assessment on the unrealized potential benefit of ICDs for primary prevention of sudden cardiac death.
|Study Type :||Observational|
|Actual Enrollment :||549 participants|
|Official Title:||"Assessment of Appropriate ICD Implantation for Primary Prevention of Sudden Cardiac Death"|
|Study Start Date :||March 2008|
|Primary Completion Date :||March 2010|
|Study Completion Date :||November 2010|
Patients with Ejection Fraction (EF) of 35% or less as determined by cardiac echocardiogram or cardiac nuclear scan.
- 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. [ Time Frame: First scheduled office visit with a Minnesota Heart Clinic Provider scheduled and conducted after the study qualifying cardiac echocardiogram or cardiac nuclear scan. ]
- A questionnaire will be issued/reviewed after completed by Providers to obtain reason(s) for not recommending ICD implant. [ Time Frame: Questionnaire will be issued after review of progress note identifies no documentation regarding possible ICD implant. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926159
|Principal Investigator:||Huagui Li, MD, PhD||University of Minnesota Physicians, Minnesota Heart Clinic|