Heart FailureERACENCT00610116
Electronic Repositioning With Acuity and Easytrak Leads
A study testing Electronic Repositioning in people with Heart Failure, run by Boston Scientific Corporation at 1 site in Germany.
Trial summary
Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine, cumulative incidence of phrenic nerve stimulation (PNS) \& success rates of Electronic Repositioning (ER) to remove it, various incl. left ventricular pacing (LVP) thresholds and PNS Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Electronic Repositioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Sep 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 receiving their FIRST implantation of a Left Ventricular (LV) lead in combination with a CRT device with implantable cardioverter defibrillator (ICD) backup and the possibility for Electronic Repositioning™
- Patients willing (= signed written consent) and capable to participate in all procedures of the study"
Who cannot join
- Patients who will not be available for routine Follow up
- 18 years old
- Known pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine, cumulative incidence of phrenic nerve stimulation (PNS) \& success rates of Electronic Repositioning (ER) to remove it, various incl. left ventricular pacing (LVP) thresholds and PNS
Read the detailed description
Bipolar leads for left ventricular pacing (LVP) such as the newly available ACUITY™ or the standard EASYTRAK™ II and EASYTRAK™ III leads from GUIDANT in combination with suitable devices for cardiac resynchronization therapy (CRT) allow for the non-invasive programming of different Left Ventricular Pacing (LVP) configurations. Hence, this Electronic Repositioning (ER) may help physicians to overcome problems in cardiac resynchronization therapy (CRT) such as ineffective biventricular pacing, high Left Ventricular Pacing (LVP) thresholds and phrenic nerve stimulation (PNS) without the need for an additional patient's operation to reposition LV leads. The ERACE study it a multi-center, prospective, non-randomized clinical study to document and evaluate appropriate performance of GUIDANT's Electronic Repositioning™ in the clinical routine with respect to the following major aspects:
avoidance of PNS and low LVP thresholds (for low battery consumption and extended device longevity) in standard cardiac resynchronization therapy (CRT)
- Conditions
- Heart Failure
- Being tested
- Electronic Repositioning
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic RepositioningDevice
Change of pacing vectors for CRT pacing
| Study group | Role | What they receive |
|---|---|---|
| LV lead electronically repositioning | Other | Single arm study Receives: Device: Electronic Repositioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)
The primary endpoint was the percentage of patients in whom PNS induced by Left Ventricular (LV) pacing could be avoided by electronic repositioning from implantation to first regular follow up (3-6 months postimplant). In this evaluation, prevention of PNS was defined as PNS appearing with the standard pacing configuration-LV tip as cathode versus Right Ventricle (RV) coil as anode-and being avoided by at least one of the three alternative reprogrammable configurations.
Measured: From implant until first follow up (occurred between 3 or 6 month after implant procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startSep 2006
- Primary completionMar 2008
- Study completionSep 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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610116
- Sponsor's protocol ID
- C007-CL-106002
- Acronym
- ERACE
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2008
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Repositioning With Acuity and Easytrak Leads
- ClinicalTrials.gov ID
- NCT00610116
- Acronym / sponsor ID
- ERACE / C007-CL-106002
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2006 (actual)
- Primary completion
- Mar 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Posted 9 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine, cumulative incidence of phrenic nerve stimulation (PNS) \& success rates of Electronic Repositioning (ER) to remove it, various incl. left ventricular pacing (LVP) thresholds and PNS
Detailed description
Bipolar leads for left ventricular pacing (LVP) such as the newly available ACUITY™ or the standard EASYTRAK™ II and EASYTRAK™ III leads from GUIDANT in combination with suitable devices for cardiac resynchronization therapy (CRT) allow for the non-invasive programming of different Left Ventricular Pacing (LVP) configurations. Hence, this Electronic Repositioning (ER) may help physicians to overcome problems in cardiac resynchronization therapy (CRT) such as ineffective biventricular pacing, high Left Ventricular Pacing (LVP) thresholds and phrenic nerve stimulation (PNS) without the need for an additional patient's operation to reposition LV leads. The ERACE study it a multi-center, prospective, non-randomized clinical study to document and evaluate appropriate performance of GUIDANT's Electronic Repositioning™ in the clinical routine with respect to the following major aspects:
avoidance of PNS and low LVP thresholds (for low battery consumption and extended device longevity) in standard cardiac resynchronization therapy (CRT)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LV lead electronically repositioning | Other | Device: Electronic RepositioningSingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving their FIRST implantation of a Left Ventricular (LV) lead in combination with a CRT device with implantable cardioverter defibrillator (ICD) backup and the possibility for Electronic Repositioning™
- Patients willing (= signed written consent) and capable to participate in all procedures of the study"
Key exclusion criteria (3 listed)
- Patients who will not be available for routine Follow up
- 18 years old
- Known pregnancy.
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 |
|---|---|---|
| Electronic RepositioningChange of pacing vectors for CRT pacing | Device | LV lead electronically repositioning |
Primary outcome
Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)
Time frame: From implant until first follow up (occurred between 3 or 6 month after implant procedure)
The primary endpoint was the percentage of patients in whom PNS induced by Left Ventricular (LV) pacing could be avoided by electronic repositioning from implantation to first regular follow up (3-6 months postimplant). In this evaluation, prevention of PNS was defined as PNS appearing with the standard pacing configuration-LV tip as cathode versus Right Ventricle (RV) coil as anode-and being avoided by at least one of the three alternative reprogrammable configurations.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Repositioning in people with Heart Failure, run by Boston Scientific Corporation at 1 site in Germany.
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 2 inclusion and 3 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 21 Apr 2021. 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 Germany. 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 9 Feb 2021). 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?
Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU) (time frame: From implant until first follow up (occurred between 3 or 6 month after implant procedure)). 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 21 Apr 2021.