EASYTRAK 3 Downsize Lead

This study has been completed.

Sponsor:

Information provided by:

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT00384722

First received: October 3, 2006

Last updated: June 23, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 3, 2006

Last Updated Date

June 23, 2009

Start Date ^ICMJE

March 2006

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Lead-related complication-free rate at one-month [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Chronic mean pacing thresholds at one-month. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Lead-related complication-free rate at one-month
Chronic mean pacing thresholds at one-month.

Change History

Complete list of historical versions of study NCT00384722 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Chronic mean R-wave amplitudes at one-month [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Chronic mean pacing impedances at one-month. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Chronic mean R-wave amplitudes at one-month
Chronic mean pacing impedances at one-month.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

EASYTRAK 3 Downsize Lead

Official Title ^ICMJE

EASYTRAK® 3 Downsize Lead Clinical Investigation

Brief Summary

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.

Detailed Description

This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Device: EASYTRAK 3 Downsize Lead

EASYTRAK 3 Downsize Lead

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

July 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Must be indicated for a Guidant CRT-P or CRT-D device
Creatinine < 2.5 mg/dL obtained no more than two weeks prior to enrollment
Age 18 or above, or of legal age to give informed consent specific to state and national law
Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
Geographically stable residents who are available for follow-up

Exclusion Criteria:

Have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate
Have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement
Have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
Currently requiring dialysis
Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
Enrolled or participating in any concurrent study, including drug investigations, without Guidant written approval, that may confound the results of this study
Have a pre-existing unipolar pacemaker that will not be explanted/abandoned
Have a mechanical tricuspid heart valve
Women who are pregnant or plan to become pregnant. Note: Women of childbearing potential must have a negative pregnancy test within seven days of enrollment.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00384722

Other Study ID Numbers ^ICMJE

Clinicals0011

Has Data Monitoring Committee

Not Provided

Responsible Party

Steven McQuillan, Director of Clinical Affairs, Boston Scientific

Study Sponsor ^ICMJE

Boston Scientific Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

John Hummel, MD

Riverside Methodist Hospital

Information Provided By

Boston Scientific Corporation

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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