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CompletedNCT00158938Updated Jun 25, 2007

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

A Phase 2/3 interventional study of EASYTRAK 3 left ventricular pacing lead in Congestive Heart Failure, sponsored by Boston Scientific Corporation. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-06-25.

Sponsored by Boston Scientific Corporation · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
115
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed 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

02

Conditions studied

  • Congestive Heart Failure

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Keywords

  • Artificial Cardiac Pacemaker
  • Implanted Electrodes
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 115 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
115 participants

Interventions

  • DeviceEASYTRAK 3 left ventricular pacing lead
06

What researchers measure

Primary outcomes

  1. Pacing thresholds at 6 months

  2. Pacing impedances at 6 months

  3. R-wave amplitudes at 6 months

  4. 6-month complication free rate

Secondary outcomes

  1. left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00158938
Lead sponsor
Boston Scientific Corporation
First posted
Sep 12, 2005
Start date
May 2003
Completion
Nov 2004
Last update
Jun 25, 2007
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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