Status:

COMPLETED

EnSite Real-Time Cardiac Performance Measurements (RT CPM) Study

Lead Sponsor:

Abbott Medical Devices

Conditions:

Heart Failure

Eligibility:

All Genders

18+ years

Brief Summary

The EnSite Real-Time Cardiac Performance Measurements Study (EnSite RT CPM) is a multicenter, international, acute, non-significant risk study, designed to enroll a maximum of 40 patient. The goal of ...

Eligibility Criteria

Inclusion

  • Be undergoing a new St. Jude Medical CRT-D or CRT-P device implantation
  • Have the ability to provide informed consent for study participation and be willing to comply with the prescribed perioperative evaluations

Exclusion

  • Have a recent myocardial infarction within 40 days prior to enrollment
  • Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
  • Be less than 18 years of age
  • Be pregnant women
  • Be currently participating in a clinical study that includes an active treatment arm

Key Trial Info

Start Date :

December 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2008

Estimated Enrollment :

21 Patients enrolled

Trial Details

Trial ID

NCT00632450

Start Date

December 1 2007

End Date

October 1 2008

Last Update

February 5 2019

Active Locations (1)

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St. Jude Medical

Sunnyvale, California, United States, 94086