Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

St. Paul, Minnesota


Purpose:

The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.


Study summary:

This is a prospective, single-armed, multi-center U.S., Australian, Canadian, and European clinical investigation, designed to demonstrate the safety and effectiveness of the EASYTRAK EPI lead in humans.


Criteria:

Inclusion Criteria: - Patients who meet the EASYTRAK EPI indications - Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law - Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol - Patients who meet any one of the following three conditions: - Meet current indications for cardiac resynchronization therapy (CRT) and epicardial placement of a pace/sense lead on the left ventricle is preferred over an endocardial lead - Meet current indications for a cardiac pacing system and have documented evidence that an endocardial lead cannot be used - Meet current indications for a cardiac pacing system and a concurrent cardiac surgical procedure is taking place where no additional surgical procedures are required to provide access to the epicardial surface of the heart Exclusion Criteria: - Patients who meet the EASYTRAK EPI contraindications - Patients who have had a myocardial infarct, unstable angina, or percutaneous coronary intervention during the preceding 30 days prior to enrollment - Patients with a documented life expectancy of less than 6 months or expected to undergo heart transplant within the next 6 months - Patients enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study - Women who are pregnant or plan to become pregnant


NCT ID:

NCT00158925


Primary Contact:

Principal Investigator
Daniel Beckman, MD
The Methodist Hospital System


Backup Contact:

N/A


Location Contact:

St. Paul, Minnesota
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.