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

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00632450
First received: February 29, 2008
Last updated: March 25, 2010
Last verified: March 2010
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by St. Jude Medical

Additional 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
Study First Received: February 29, 2008
Last Updated: March 25, 2010
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014