Detect Fluid Early From Intra-thoracic Impedance Monitoring (DEFEAT-PE)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by St. Jude Medical.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

St. Jude Medical

ClinicalTrials.gov Identifier:

NCT00916929

First received: June 8, 2009

Last updated: April 4, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 8, 2009
Last Updated Date	April 4, 2011
Start Date ^ICMJE	May 2009
Estimated Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 8, 2009)	The primary endpoint is intended to demonstrate that the number of departures from the stability zone that are unrelated to a pulmonary congestion event (False Positive) per patient-year of follow-up is less than 1.5. [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00916929 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 8, 2009)	Sensitivity of the index to detect events will be calculated as the proportion of events with a related departure. [ Time Frame: 6-months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Detect Fluid Early From Intra-thoracic Impedance Monitoring
Official Title ^ICMJE	Not Provided
Brief Summary	To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic
Condition ^ICMJE	Heart Failure
Intervention ^ICMJE	Device: Impedance Monitoring Feature Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
Study Arm (s)	ICD Intervention: Device: Impedance Monitoring Feature CRT-D Intervention: Device: Impedance Monitoring Feature
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	162
Estimated Completion Date	September 2011
Estimated Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Must have SJM ICD or CRT-D for at least 31 days Must have had an episode of ADHF within past 6 months Exclusion Criteria: History of kidney disease requiring hemodialysis Refractory end stage heart failure
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00916929
Other Study ID Numbers ^ICMJE	40006062/D
Has Data Monitoring Committee	No
Responsible Party	Tamara Shipman, St Jude Medical
Study Sponsor ^ICMJE	St. Jude Medical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	St. Jude Medical
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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