Heart FailureELEVATE 3NCT01539629
ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0
An observational study of Heart Failure, run by Boston Scientific Corporation at 4 sites in United States.
Trial summary
This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D device to 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?
- Cardiac pacing
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2012to Nov 2012
- 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.
Who may be able to join
- Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
- Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without an active right atrial lead
- Patients who have an active LV bipolar or unipolar lead
- Patients who have an active RV defibrillation lead
- Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
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 as defined as VVI 40 without intrinsic atrial or ventricular activity
- Patients who will not tolerate a pacing pause of up to 6 seconds
- Patients with a pre-existing unipolar pacemaker
- Patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes
- Patients enrolled in any concurrent study, without Boston Scientific CRM written approval
- Women who are pregnant;women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Genesis Medical Center
Davenport, Iowa, 52803
Virginia Commonwealth University Health System
Richmond, Virginia, 23298-0053
Wheaton Franciscan Health Care
Wauwatosa, Wisconsin, 53226
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, 19067
About this study
Official title: Evaluation of Left Ventricular Autothreshold
This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D device to evaluate a new feature for future heart failure devices.
Read the detailed description
ELEVATE 3.0 is an acute, prospective, multicenter feasibility study which is randomized within a patient test sequence and pulse width. The study is designed to characterize the performance of LVAT (Left Ventricular Authothreshold) feature.
- Conditions
- Heart Failure
- Being tested
- Cardiac pacing
- Keywords
- Heart failure, Autothreshold, Pacing, CRT-D recipients, Left Ventricular 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.
Cardiac pacingDevice
Also called COGNIS PG.
Cadiac pacing via a pulse generator and implaned intracardiac leads.
| Study group | Role | What they receive |
|---|---|---|
| Pulse Width | One group reflecting two different pulse widths. Receives: Device: Cardiac pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing.
The primary objective of this study is to collect real-time signals during LV pacing and voltage step-down from patients with implanted COGNIS devices.
Measured: Minimum of 24 hrs 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 posted27 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionNov 2012
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth L Ellenbogen, MD, Principal investigator, Virginia Commonwealth University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539629
- Sponsor's protocol ID
- ELEVATE 3.0
- Acronym
- ELEVATE 3
- Status last verified
- Oct 2012
- First submitted
- 22 Feb 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Autothreshold
- ClinicalTrials.gov ID
- NCT01539629
- Acronym / sponsor ID
- ELEVATE 3 / ELEVATE 3.0
- Conditions
- Heart Failure
- Keywords
- Heart failure, Autothreshold, Pacing, CRT-D recipients, Left Ventricular evoked response signals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Feb 2012 (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 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D device to evaluate a new feature for future heart failure devices.
Detailed description
ELEVATE 3.0 is an acute, prospective, multicenter feasibility study which is randomized within a patient test sequence and pulse width. The study is designed to characterize the performance of LVAT (Left Ventricular Authothreshold) feature.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse Width | – | Device: Cardiac pacingOne group reflecting two different pulse widths. |
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.
Key inclusion criteria (5 listed)
- Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
- Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without an active right atrial lead
- Patients who have an active LV bipolar or unipolar lead
- Patients who have an active RV defibrillation lead
- Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
Key exclusion criteria (7 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 as defined as VVI 40 without intrinsic atrial or ventricular activity
- Patients who will not tolerate a pacing pause of up to 6 seconds
- Patients with a pre-existing unipolar pacemaker
- Patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes
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 |
|---|---|---|
| Cardiac pacingAlso: COGNIS PG.Cadiac pacing via a pulse generator and implaned intracardiac leads. | Device | Pulse Width |
Primary outcome
Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing.
Time frame: Minimum of 24 hrs post CRT-D implant.
The primary objective of this study is to collect real-time signals during LV pacing and voltage step-down from patients with implanted COGNIS devices.
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 5 Dec 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, MD principal investigator
Virginia Commonwealth University Health System
4 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 4 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 5 inclusion and 7 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 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing. (time frame: Minimum of 24 hrs 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 5 Dec 2012.