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

February 1, 2019 updated by: Abbott Medical Devices

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.

Study Overview

Status

Completed

Conditions

Heart Failure

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Sunnyvale, California, United States, 94086
    - St. Jude Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients indicated for implantation of a CRT pulse generator

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

Principal Investigator: Johannes Sperzel, MD, Kerckhoff Klinik GmbH
Principal Investigator: Andre d'Avila, MD, Massachusetts General Hospital
Principal Investigator: Imran Niazi, MD, Arrhythmia Center of Southern Wisconsin, Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Sperzel J, Brandt R, Hou W, Doelger A, Zdarek J, Rosenberg SP, Ryu K, Koh S, Yang M. Intraoperative characterization of interventricular mechanical dyssynchrony using electroanatomic mapping system--a feasibility study. J Interv Card Electrophysiol. 2012 Nov;35(2):189-96. doi: 10.1007/s10840-012-9695-0. Epub 2012 Jun 14.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)