Heart FailureNCT01977703
Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
A study testing Ultra Conservative ICD Programming and Traditional ICD Programming in people with Heart Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy… 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?
- Ultra Conservative ICD Programming and Traditional ICD Programming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2016
- Phase
- Interventional
- 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
- Age ≥ 18
- Advanced Heart Failure
- Scheduled for Heartmate II LVAD implant
- With existing ICD
Who cannot join
- -Age < 18
Trial locations and contacts
1 site in 1 country.
About this study
We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. Avoiding CIED (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.
- Conditions
- Heart Failure
- Being tested
- Ultra Conservative ICD Programming, Traditional ICD Programming
- Keywords
- Heart Failure, Advanced Heart Failure, LVAD, Left Ventricular Assist Device, Heart-Assist Devices
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra Conservative ICD ProgrammingOther
Traditional ICD ProgrammingOther
| Study group | Role | What they receive |
|---|---|---|
| Traditional ICD Programming | Active comparator | ICD will be set to pre-LVAD settings post LVAD implant. Receives: Other: Traditional ICD Programming |
| Ultra Conservative ICD Programming | Experimental | ICD will be set to ultra conservative settings post LVAD implant. Receives: Other: Ultra Conservative ICD Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first ICD shock following LVAD implant
Measured: Within 12 months following LVAD implant
Secondary outcomes (6)
Frequency of anti-tachycardia pacing (ATP) therapy administration for appropriate or inappropriate arrhythmia detection
Number of ATP occurrences
Measured: Within 12 months following LVAD implant
Frequency of ICD generator change prior to definitive therapy
Number of patients requiring ICD generator change
Measured: Within 12 months following LVAD implant
Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes
Battery voltage and battery life measured in days
Measured: Within 12 months following LVAD implant
Frequency of arrhythmic syncope
Number of syncope occurrences
Measured: Within 12 months following LVAD implant
Hospitalization frequency for decompensated congestive heart failure
Number of hospitalizations
Measured: Within 12 months following LVAD implant
Determine survival to heart transplantation following LVAD implant
Number of patients, post LVAD implant, to receive heart transplant and number of survival days post implant
Measured: Within 12 months following LVAD implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Thoratec Corporation
- Responsible party
- Principal investigator, Christopher Ellis, Vanderbilt University Medical Center
- Investigators
- Christopher Ellis, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977703
- Sponsor's protocol ID
- 131336
- Status last verified
- Aug 2017
- First submitted
- 30 Oct 2013
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Richardson TD, Hale L, Arteaga C, Xu M, Keebler M, Schlendorf K, Danter M, Shah A, Lindenfeld J, Ellis CR. Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device. J Am Heart Assoc. 2018 Feb 23;7(5):e007748. doi: 10.1161/JAHA.117.007748.
PubMed 29475875
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
- ClinicalTrials.gov ID
- NCT01977703
- Acronym / sponsor ID
- 131336
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Advanced Heart Failure, LVAD, Left Ventricular Assist Device, Heart-Assist Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Thoratec Corporation
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Nov 2013 (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.
We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. Avoiding CIED (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional ICD Programming | Active comparator | Other: Traditional ICD ProgrammingICD will be set to pre-LVAD settings post LVAD implant. |
| Ultra Conservative ICD Programming | Experimental | Other: Ultra Conservative ICD ProgrammingICD will be set to ultra conservative settings post LVAD implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Advanced Heart Failure
- Scheduled for Heartmate II LVAD implant
- With existing ICD
Key exclusion criteria (1 listed)
- -Age < 18
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 |
|---|---|---|
| Ultra Conservative ICD Programming | Other | Ultra Conservative ICD Programming |
| Traditional ICD Programming | Other | Traditional ICD Programming |
Primary outcome
Time to first ICD shock following LVAD implant
Time frame: Within 12 months following LVAD implant
6 secondary outcomes
Frequency of anti-tachycardia pacing (ATP) therapy administration for appropriate or inappropriate arrhythmia detection
Time frame: Within 12 months following LVAD implant
Frequency of ICD generator change prior to definitive therapy
Time frame: Within 12 months following LVAD implant
Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes
Time frame: Within 12 months following LVAD implant
Frequency of arrhythmic syncope
Time frame: Within 12 months following LVAD implant
Hospitalization frequency for decompensated congestive heart failure
Time frame: Within 12 months following LVAD implant
Determine survival to heart transplantation following LVAD implant
Time frame: Within 12 months following LVAD 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 16 Aug 2017.
- Derived from this study: PubMed 29475875Richardson TD, Hale L, Arteaga C, Xu M, Keebler M, Schlendorf K, Danter M, Shah A, Lindenfeld J, Ellis CR. Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device. J Am Heart Assoc. 2018 Feb 23;7(5):e007748. doi: 10.1161/JAHA.117.007748.
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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.
Christopher Ellis, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra Conservative ICD Programming and Traditional ICD Programming in people with Heart Failure, run by Vanderbilt University Medical Center 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 4 inclusion and 1 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 16 Aug 2017. 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?
Time to first ICD shock following LVAD implant (time frame: Within 12 months following LVAD implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01977703, which also lists 1 linked publication.
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 16 Aug 2017.