EnSite Real-Time Cardiac Performance Measurements (RT CPM) Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2019 |
| Start Date: | December 2007 |
| End Date: | October 2008 |
EnSite Real-Time Cardiac Performance Measurements Study, a Non-significant Risk Study
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.
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.
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
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