Heart FailureELEVATENCT00812201
Evaluation of Left Ventricular AutoThreshold
An observational study of Heart Failure, run by Boston Scientific Corporation at 2 sites in United States.
Trial summary
This study will collect data on a new feature for future heart failure devices via an external non-implantable system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Oct 2009
- 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: Primary care clinic
Who may be able to join
- Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
- Patients who are willing and capable of participating in all testing associated with this study
- Patients who are 18 or above, or of legal age to give informed consent specific to state and national law
Who cannot join
- Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, 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 (unless the Investigator intends to replace them with permitted leads)
- Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
- Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
- Patients with a prosthetic mechanical tricuspid heart valve
- Women who are pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Monongalia General Hospital
Morgantown, West Virginia, 26505
Virginia Commonwealth University Health System
Richmond, Virginia, 23298
About this study
This study will collect data on a new feature for future heart failure devices via an external non-implantable system.
Read the detailed description
ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.
- Conditions
- Heart Failure
- Being tested
- No intervention is used. Collection of signals only.
- Keywords
- Heart failure, auto threshold, pacing, CRT-P or CRT-D recipients, threshold measurements
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is used. Collection of signals only.Device
Device received per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Device: No intervention is used. Collection of signals only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective of this study is to collect data to characterize the performance of the LVAT feature.
Measured: Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2009
- Study completionOct 2009
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
- 80 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
- NCT00812201
- Sponsor's protocol ID
- CRRT081908H
- Acronym
- ELEVATE
- Status last verified
- Jun 2022
- First submitted
- 18 Dec 2008
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular AutoThreshold
- ClinicalTrials.gov ID
- NCT00812201
- Acronym / sponsor ID
- ELEVATE / CRRT081908H
- Conditions
- Heart Failure
- Keywords
- Heart failure, auto threshold, pacing, CRT-P or CRT-D recipients, threshold measurements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Dec 2008 (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 on a new feature for future heart failure devices via an external non-implantable system.
Detailed description
ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: No intervention is used. Collection of signals only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- Patients who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
- Patients who are willing and capable of participating in all testing associated with this study
- Patients who are 18 or above, or of legal age to give informed consent specific to state and national law
Key exclusion criteria (6 listed)
- Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, 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 (unless the Investigator intends to replace them with permitted leads)
- Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
- Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
- Patients with a prosthetic mechanical tricuspid heart valve
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 |
|---|---|---|
| No intervention is used. Collection of signals only.Device received per standard of care. | Device | 1 |
Primary outcome
The objective of this study is to collect data to characterize the performance of the LVAT feature.
Time frame: Implant
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 28 Jun 2022.
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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
2 sites 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 2 sites 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 3 inclusion and 6 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The objective of this study is to collect data to characterize the performance of the LVAT feature. (time frame: 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 28 Jun 2022.