CompletedNot Applicable

A Study Comparing the Sensed R Wave in Bipolar and Extended Bipolar Configurations

United States50 participantsStarted 2009-12

Plain-language summary

The PropR study will evaluate sensing during ventricular fibrillation (VF) in both bipolar and extended bipolar configurations, in order to evaluate if both can be used interchangeably in caring for patients. In addition, follow up evaluation of R wave amplitude over time would allow us to determine whether one configuration is more likely to be associated with change. This understanding would be important in selecting the proper configuration at the time of implant.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age \> 18 with ability to give informed consent, * patients who are expected to live more than one year, * patients with indication for defibrillator implant, * patients who are not pacemaker dependent, * patients with either ischemic or nonischemic cardiomyopathy. Exclusion Criteria: * age \< 18, * inability to give informed consent, * life expectancy less than one year, * pacemaker dependence, or use of preexisting lead for sensing, * any condition which would preclude ICD testing at the end of the implant, * patients who are undergoing upgrade to an ICD from a pacemaker will also be excluded, * patients with inherited arrhythmias or ion channel related arrhythmias will be excluded from the study.

What they're measuring

Duration of sensing (time to detection) in VF at the time of implant.

Timeframe: At implant

Trial details

NCT IDNCT01032577

SponsorTrinity Health Of New England

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-07

View on ClinicalTrials.gov More Ischemic and Nonischemic Cardiomyopathy, With Primary and Secondary Implant Indications trials