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

EnSite Real-Time Cardiac Performance Measurements Study, a Non-significant Risk Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00632450

Acronym

EnSite RT CPM

Enrollment

Registered

2008-03-10

Start date

2007-12-31

Completion date

2008-10-31

Last updated

2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results