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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT01032577
First received: December 14, 2009
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  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:

MedlinePlus related topics: Cardiomyopathy
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensing in sinus rhythm at one month [ Time Frame: One month post implant ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01032577     History of Changes
Other Study ID Numbers: 10-01-005-E
Study First Received: December 14, 2009
Last Updated: February 27, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ischemia
Cardiomyopathies
Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013