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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032577
First Posted: December 15, 2009
Last Update Posted: February 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Saint Francis Care
  Purpose
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.

Condition
Ischemic and Nonischemic Cardiomyopathy, With Primary and Secondary Implant Indications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Comparing the Sensed R Wave in Bipolar and Extended Bipolar Configurations

Resource links provided by NLM:


Further study details as provided by Saint Francis Care:

Primary Outcome Measures:
  • Duration of sensing (time to detection) in VF at the time of implant. [ Time Frame: At implant ]

Secondary Outcome Measures:
  • Sensing in sinus rhythm at one month [ Time Frame: One month post implant ]

Enrollment: 50
Study Start Date: December 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
cardiomyopathy, with implant indications
30-50 volunteers age >18, male and female with ability to give informed consent, who are expected to live more than one year, with indication for defibrillator implant and who are not pacemaker dependent.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient population will include approximately 30-50 volunteers age >18, male and female, both ischemic and nonischemic cardiomyopathy, with primary and secondary implant indications.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032577


Locations
United States, Connecticut
St Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Saint Francis Care
Medtronic
Investigators
Principal Investigator: Aneesh Tolat, MD Attending Cardiac Electrophysiologist, St Francis Hospital and Medical Center
  More Information

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01032577     History of Changes
Other Study ID Numbers: 10-01-005-E
First Submitted: December 14, 2009
First Posted: December 15, 2009
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by Saint Francis Care:
ischemic cardiomyopathy
nonischemic cardiomyopathy
implant
bipolar sensing
extended bipolar sensing

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases