Congestive Heart FailurePhase 2/3NCT00158938
Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
A Phase 2/3 study testing EASYTRAK 3 left ventricular pacing lead in people with Congestive Heart Failure, run by Boston Scientific Corporation.
Trial summary
The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- EASYTRAK 3 left ventricular pacing lead
- Type of treatment
- Medical device
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Nov 2004
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
About this study
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
- Conditions
- Congestive Heart Failure
- Being tested
- EASYTRAK 3 left ventricular pacing lead
- Keywords
- Artificial Cardiac Pacemaker, Implanted Electrodes
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EASYTRAK 3 left ventricular pacing leadDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Pacing thresholds at 6 months
Pacing impedances at 6 months
R-wave amplitudes at 6 months
6-month complication free rate
Secondary outcomes (1)
left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
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 startMay 2003
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158938
- Sponsor's protocol ID
- Clinicals0007
- Status last verified
- Jun 2007
- First submitted
- 8 Sep 2005
- Last updated
- 25 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
- ClinicalTrials.gov ID
- NCT00158938
- Acronym / sponsor ID
- Clinicals0007
- Conditions
- Congestive Heart Failure
- Keywords
- Artificial Cardiac Pacemaker, Implanted Electrodes
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Nov 2004 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 3 left ventricular pacing lead | Device | – |
Primary outcome
Pacing thresholds at 6 months
Pacing impedances at 6 months
R-wave amplitudes at 6 months
6-month complication free rate
1 secondary outcome
left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2007.
Related trials for Congestive Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EASYTRAK 3 left ventricular pacing lead in people with Congestive Heart Failure, run by Boston Scientific Corporation.
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 4 inclusion and 9 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 25 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pacing thresholds at 6 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 25 Jun 2007.