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

NCT01032577 | Completed

• 1 other identifier: 10-01-005-E
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic and Nonischemic Cardiomyopathy, With Primary and Secondary Implant Indications

Keywords

ischemic cardiomyopathy; nonischemic cardiomyopathy; implant; bipolar sensing; extended bipolar sensing

Outcome Measures

Primary Outcomes (1)

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

  At implant

Secondary Outcomes (1)

• Sensing in sinus rhythm at one month

  One month post implant

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Trinity Health Of New England: lead
• Medtronic: collaborator

Study Sites (1)

St Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aneesh Tolat, MD

  Attending Cardiac Electrophysiologist, St Francis Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: December 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (1)