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

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
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, see Learn About Clinical Studies.

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 October 19, 2014