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

Completed

Conditions studied: Heart Failure

In brief

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 the study is to collect 3-D systolic/diastolic data with the EnSite NavX Mapping system during a CRT implant. Patients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite NavX Mapping system during the implantation of a cardiac resynchronization therapy device.

Key facts

Study ID

NCT00632450

Run by

Abbott Medical Devices

People needed

21

Starts

2007-12-01

Expected to finish

2008-10-01

Last updated by the study team

2019-02-05

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Jude Medical — Sunnyvale, California, United States

Full record on ClinicalTrials.gov

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