Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead

Congestive Heart Failure Clinical Trial

Official title:

Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158938
• Other study ID #: Clinicals0007
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 8, 2005
• Last updated: June 22, 2007
• Start date: May 2003
• Est. completion date: November 2004

Study information

• Verified date: June 2007
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead

Description:

This clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the EASYTRAK 3 lead in humans. Patients implanted with the EASYTRAK 3 lead were followed through pre-discharge, 1-month, 3-month and 6-month follow-ups

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF <= 35%) and QRS duration >= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy.

• 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 investigational center and at the intervals defined by this protocol.

Exclusion Criteria:

• A known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate.

• Previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement.

• Pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads).

• Requiring dialysis.

• A myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment.

• Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).

• A documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months.

• Enrolled in any concurrent study, without prior Guidant written approval, that may confound the results of this study.

• Have a mechanical tricuspid heart valve.

Study Design

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• EASYTRAK 3 left ventricular pacing lead

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pacing thresholds at 6 months
Primary	Pacing impedances at 6 months
Primary	R-wave amplitudes at 6 months
Primary	6-month complication free rate
Secondary	left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety