Heart FailureELEVATE 2NCT01242722
Evaluation of Left Ventricular Autothreshold, Phase Two
An observational study of Heart Failure, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices. 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?
- CRT-D
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2011
- Phase
- Observational
- 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
Study population: The study population will be a sample of patients with COGNIS CRT-D devices and bipolar LV leads.
Who may be able to join
- Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without a right atrial lead
- Patients who have an active LV bipolar lead
- Patients who have an active right ventricular (RV) defibrillation lead
- Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
- Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
Who cannot join
- Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining
- Patients who are pacemaker-dependent
- Patients who will not tolerate a pacing pause of up to 6 seconds
- Patients who have a unipolar LV pace/sense lead, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
- Patients with pre-existing leads other than those specified in this investigational plan
- Patients with a pre-existing unipolar pacemaker
Show all 9Show fewer
- Patients who are unable or unwilling to maintain a supine or sitting position for 40-50 minutes
- Patients enrolled in any concurrent study, without Boston Scientific written approval
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional Cardiovascular Medical Center
Stuebenville, Ohio, 43952
About this study
This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.
Read the detailed description
ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) feature.
- Conditions
- Heart Failure
- Being tested
- CRT-D
- Keywords
- Heart failure, auto threshold, pacing, CRT-D recipients, Left Ventricular (LV) evoked response signals
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT-DDevice
Cardiac pacing via a pulse generator and implanted intracardiac leads
| Study group | Role | What they receive |
|---|---|---|
| 1 | Two experimental and/or intervention groups under 1 arm. Receives: Device: CRT-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing
The primary objective of this study is to collect real-time signals during LV pacing voltage step-down from patients with implanted COGNIS CRT-D devices in a follow-up setting. This data will be used to assess the stability of the LV evoked response electrogram signal and will be used in an offline assessment of the LVAT algorithm. One or two data points will be collected per patient in the trial. Patients must be at least 24 hours post implant of their COGNIS CRT-D device
Measured: At least 24 hours post CRT-D implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth L Ellenbogen, M.D., Principal investigator, Virginia Commonwealth University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242722
- Sponsor's protocol ID
- ELEVATE 2.0
- Acronym
- ELEVATE 2
- Status last verified
- Oct 2012
- First submitted
- 12 Nov 2010
- Last updated
- 3 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Autothreshold, Phase Two
- ClinicalTrials.gov ID
- NCT01242722
- Acronym / sponsor ID
- ELEVATE 2 / ELEVATE 2.0
- Conditions
- Heart Failure
- Keywords
- Heart failure, auto threshold, pacing, CRT-D recipients, Left Ventricular (LV) evoked response signals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 Nov 2010 (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.
This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.
Detailed description
ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) feature.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: CRT-DTwo experimental and/or intervention groups under 1 arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be a sample of patients with COGNIS CRT-D devices and bipolar LV leads.
Key inclusion criteria (5 listed)
- Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without a right atrial lead
- Patients who have an active LV bipolar lead
- Patients who have an active right ventricular (RV) defibrillation lead
- Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
- Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
Key exclusion criteria (9 listed)
- Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining
- Patients who are pacemaker-dependent
- Patients who will not tolerate a pacing pause of up to 6 seconds
- Patients who have a unipolar LV pace/sense lead, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
- Patients with pre-existing leads other than those specified in this investigational plan
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 |
|---|---|---|
| CRT-DCardiac pacing via a pulse generator and implanted intracardiac leads | Device | 1 |
Primary outcome
Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing
Time frame: At least 24 hours post CRT-D implant
The primary objective of this study is to collect real-time signals during LV pacing voltage step-down from patients with implanted COGNIS CRT-D devices in a follow-up setting. This data will be used to assess the stability of the LV evoked response electrogram signal and will be used in an offline assessment of the LVAT algorithm. One or two data points will be collected per patient in the trial. Patients must be at least 24 hours post implant of their COGNIS CRT-D device
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 3 Oct 2012.
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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.
Kenneth L Ellenbogen, M.D. principal investigator
Virginia Commonwealth University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 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 3 Oct 2012. 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?
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?
Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing (time frame: At least 24 hours post CRT-D implant). 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 3 Oct 2012; AzTrials last refreshed its copy on 27 Oct 2026.