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

Completed

• Conditions: Heart Failure

• Registration Number: NCT00632450
• Lead Sponsor: Abbott Medical Devices

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-10
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

St. Jude Medical; 🇺🇸 Sunnyvale, California, United States