NCT00158925

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

April 28, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

3.4 years

First QC Date

September 8, 2005

Results QC Date

March 17, 2017

Last Update Submit

May 2, 2017

Conditions

BradycardiaCongestive Heart Failure

Keywords

Artificial Cardiac PacingImplanted Electrodes

Outcome Measures

Primary Outcomes (4)

  • Chronic Pacing Thresholds at 3 Months

    The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.

    3 months

  • Chronic Pacing Impedances at 3 Months

    The expected mean impedance is 500 Ohms.

    3 months

  • Chronic Sensing Amplitudes at 3 Months

    The expected mean is 10mV.

    3 months

  • Lead-related Complication-free Rate at 3 Months

    The estimated target value for this endpoint is 80%.

    3 months

Secondary Outcomes (1)

  • Lead Implant Time

    Implant

Study Arms (1)

EASYTRAK EPI Lead

EXPERIMENTAL

Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead.

Device: EASYTRAK EPI lead

Interventions

EASYTRAK EPI leadDEVICE

EASYTRAK EPI lead

EASYTRAK EPI Lead

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Locations in the US

Saint Paul, Minnesota, 55112, United States

Location

MeSH Terms

Conditions

BradycardiaHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Elke Sommerijns
Organization
Boston Scientific
elke.sommerijns@bsci.com
+32 479 76 71 56

Study Officials

  • Daniel Beckman, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2004

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

May 31, 2017

Results First Posted

April 28, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)