BradycardiaEASYTRAK EPINCT00158925
The EASYTRAK EPI Clinical Investigation
A study testing EASYTRAK EPI lead in people with Bradycardia and Congestive Heart Failure, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Congestive Heart Failure
- What is being tested?
- EASYTRAK EPI lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Feb 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Multiple Locations in the US
Saint Paul, Minnesota, 55112
About this study
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
Read the detailed description
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.
- Conditions
- Bradycardia, Congestive Heart Failure
- Being tested
- EASYTRAK EPI lead
- Keywords
- Artificial Cardiac Pacing, Implanted Electrodes
- Medical subject headings
- Bradycardia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EASYTRAK EPI leadDevice
EASYTRAK EPI lead
| Study group | Role | What they receive |
|---|---|---|
| EASYTRAK EPI Lead | Experimental | Subjects in this arm will be implanted or attempted with the EASYTRAK EPI lead. Receives: Device: EASYTRAK EPI lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Pacing Thresholds at 3 Months
The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.
Measured: 3 months
Chronic Pacing Impedances at 3 Months
The expected mean impedance is 500 Ohms.
Measured: 3 months
Chronic Sensing Amplitudes at 3 Months
The expected mean is 10mV.
Measured: 3 months
Lead-related Complication-free Rate at 3 Months
The estimated target value for this endpoint is 80%.
Measured: 3 months
Secondary outcomes (1)
Lead Implant Time
The estimated target value for average implant time is 30 minutes. Unit of measure will be the time period needed for the implant.
Measured: Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Beckman, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158925
- Sponsor's protocol ID
- Clinicals0001
- Acronym
- EASYTRAK EPI
- Status last verified
- May 2017
- First submitted
- 8 Sep 2005
- Last updated
- 31 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EASYTRAK EPI Clinical Investigation
- ClinicalTrials.gov ID
- NCT00158925
- Acronym / sponsor ID
- EASYTRAK EPI / Clinicals0001
- Conditions
- Bradycardia, Congestive Heart Failure
- Keywords
- Artificial Cardiac Pacing, Implanted Electrodes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 28 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EASYTRAK EPI Lead | Experimental | Device: EASYTRAK EPI leadSubjects in this arm will be implanted or attempted with the EASYTRAK EPI lead. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EASYTRAK EPI leadEASYTRAK EPI lead | Device | EASYTRAK EPI Lead |
Primary outcome
Chronic Pacing Thresholds at 3 Months
Time frame: 3 months
The expected mean pacing threshold is 1.9V at 0.5 ms pulse width.
Chronic Pacing Impedances at 3 Months
Time frame: 3 months
The expected mean impedance is 500 Ohms.
Chronic Sensing Amplitudes at 3 Months
Time frame: 3 months
The expected mean is 10mV.
Lead-related Complication-free Rate at 3 Months
Time frame: 3 months
The estimated target value for this endpoint is 80%.
1 secondary outcome
Lead Implant Time
Time frame: Implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Beckman, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EASYTRAK EPI lead in people with Bradycardia and Congestive Heart Failure, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Pacing Thresholds at 3 Months (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.