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

Completed

Conditions studied: Ischemic and Nonischemic Cardiomyopathy, With Primary and Secondary Implant Indications

In brief

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.

Key facts

Study ID

NCT01032577

Run by

Trinity Health Of New England

People needed

50

Starts

2009-12-01

Expected to finish

2011-07-01

Last updated by the study team

2012-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St Francis Hospital and Medical Center — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.