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Sponsors and Collaborators: |
Medtronic Cardiac Rhythm Disease Management Medtronic |
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Information provided by: | Medtronic Cardiac Rhythm Disease Management |
ClinicalTrials.gov Identifier: | NCT00279955 |
The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart failure related adverse events and health care utilization.
Condition | Intervention |
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Heart Failure, Congestive |
Device: Cardiac Resynchronization Therapy Device |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure |
Enrollment: | 1024 |
Study Start Date: | June 2004 |
Study Completion Date: | June 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients receiving a specified Medtronic Implantable Cardiac Resynchronization Therapy Defibrillator device where informed consent and/or authorization to use and disclose health information permission has been granted.
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | David Whellan, MD | Jefferson Heart Institute |
Responsible Party: | Medtronic CRDM ( CRDM Core Clinical ) |
Study ID Numbers: | 235 |
Study First Received: | January 18, 2006 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00279955 |
Health Authority: | United States: Institutional Review Board |
Heart Failure, Congestive Implantable Cardioverter-Defibrillators |
Heart Failure Heart Diseases |
Cardiovascular Diseases |