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

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

This study is currently recruiting participants.

Verified by St. Jude Medical, January 2009

First Received: February 29, 2008 Last Updated: January 22, 2009 History of Changes

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00632450

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:	Prospective
Official Title:	EnSite Real-Time Cardiac Performance Measurements Study, a Non-Significant Risk Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

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

Contacts

Contact: Tamara Shipman

800-733-3455

tshipman@sjm.com

Locations

United States, California
St. Jude Medical	Recruiting
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

Responsible Party:	St. Jude Medical ( Michael Yang/Director of Research )
Study ID Numbers:	40004879
Study First Received:	February 29, 2008
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00632450 History of Changes
Health Authority:	United States: Institutional Review Board; Germany: Ethics Commission

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009