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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632450
First Posted: March 10, 2008
Last Update Posted: March 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St. Jude Medical
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: EnSite Real-Time Cardiac Performance Measurements Study, a Non-significant Risk Study

Further study details as provided by St. Jude Medical:

Enrollment: 21
Study Start Date: December 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients indicated for implantation of a CRT pulse generator
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632450


Locations
United States, California
St. Jude Medical
Sunnyvale, California, United States, 94086
Sponsors and Collaborators
St. Jude Medical
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Yang/Director of Research, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00632450     History of Changes
Other Study ID Numbers: 40004879
First Submitted: February 29, 2008
First Posted: March 10, 2008
Last Update Posted: March 29, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases