Congestive Heart FailureEXPECTNCT01520714
Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)
A study testing Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead in people with Congestive Heart Failure, run by Baylor Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2011
- 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
- Greater than 18 years of age and able to provide informed consent
- Planned placement of a Medtronic LV pacing lead and a Medtronic ICD generator with LVCM technology
- Geographically stable and able to follow-up for a period of at least six months post-procedure at The Heart Hospital Baylor Plano
- Willingness to comply with the requirements of the protocol
Who cannot join
- Life expectancy of less than six months
- Plans for or significant possibility of pregnancy during the required follow-up window
- Significant cardiovascular surgery planned within six months following ICD implant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Posture on LV Transvenous Lead Capture Thresholds (EXPECT)
The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.
Read the detailed description
Traditionally clinicians program the safety margins for the right atrial, right ventricular, and left ventricular leads two-times the capture thresholds. This safety margin is necessary for the right atrial and right ventricular outputs to prevent asystole during fluctuation of capture thresholds. This two-times safety margin may not be necessary for the left ventricular lead output and may be causing shorter device battery longevity. Newly implemented LV capture threshold management algorithms may help maintain a proper balance of safety margin and battery longevity. However, recent research conducted on automatic left ventricular capture measurement (LVCM) shows as much as 3.5 V daily variability in capture thresholds. In this same study, 18% of patients had >1.5 V LV threshold variability. A possible explanation for the variability of LV thresholds is lead stability. Small movements of the lead electrodes associated with movement of patient posture may account for daily fluctuation of capture thresholds. As heart failure patient care and therapies improve, CRT patients may survive longer than the projected longevities of their device. In order to minimize patient risks associated with device change-outs, care must be taken to maximize battery longevity while maintaining CRT pacing. Examining patient posture changes as a possible cause of threshold variability may guide clinicians to program more appropriate LV outputs with patient safety and device longevity in mind.
- Conditions
- Congestive Heart Failure
- Being tested
- Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead
- Keywords
- Congestive Heart Failure (CHF), Cardiac Resynchronization Therapy (CRT), BiVentricular Implantable Cardioverter Defibrillator (BiVICD), Fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV leadDevice
1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.
| Study group | Role | What they receive |
|---|---|---|
| Medtronic passive fixation LV lead | Experimental | Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Receives: Device: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead |
| Medtronic 4195 Active Fixation LV Lead | Experimental | Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule Receives: Device: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Change in Threshold of >1 Volt With Posture Changes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Lower enrollment rate than expected
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 Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- James B DeVille, M.D., Principal investigator, Baylor Research Institute - The Heart Hospital Baylor Plano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520714
- Sponsor's protocol ID
- 009-067
- Acronym
- EXPECT
- Status last verified
- Apr 2014
- First submitted
- 22 Feb 2010
- Last updated
- 26 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Posture on LV Transvenous Lead Capture Thresholds (EXPECT)
- ClinicalTrials.gov ID
- NCT01520714
- Acronym / sponsor ID
- EXPECT / 009-067
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure (CHF), Cardiac Resynchronization Therapy (CRT), BiVentricular Implantable Cardioverter Defibrillator (BiVICD), Fraction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lower enrollment rate than expected
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Posted 26 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.
Detailed description
Traditionally clinicians program the safety margins for the right atrial, right ventricular, and left ventricular leads two-times the capture thresholds. This safety margin is necessary for the right atrial and right ventricular outputs to prevent asystole during fluctuation of capture thresholds. This two-times safety margin may not be necessary for the left ventricular lead output and may be causing shorter device battery longevity. Newly implemented LV capture threshold management algorithms may help maintain a proper balance of safety margin and battery longevity. However, recent research conducted on automatic left ventricular capture measurement (LVCM) shows as much as 3.5 V daily variability in capture thresholds. In this same study, 18% of patients had >1.5 V LV threshold variability. A possible explanation for the variability of LV thresholds is lead stability. Small movements of the lead electrodes associated with movement of patient posture may account for daily fluctuation of capture thresholds. As heart failure patient care and therapies improve, CRT patients may survive longer than the projected longevities of their device. In order to minimize patient risks associated with device change-outs, care must be taken to maximize battery longevity while maintaining CRT pacing. Examining patient posture changes as a possible cause of threshold variability may guide clinicians to program more appropriate LV outputs with patient safety and device longevity in mind.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medtronic passive fixation LV lead | Experimental | Device: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV leadMedtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule |
| Medtronic 4195 Active Fixation LV Lead | Experimental | Device: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV leadMedtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than 18 years of age and able to provide informed consent
- Planned placement of a Medtronic LV pacing lead and a Medtronic ICD generator with LVCM technology
- Geographically stable and able to follow-up for a period of at least six months post-procedure at The Heart Hospital Baylor Plano
- Willingness to comply with the requirements of the protocol
Key exclusion criteria (3 listed)
- Life expectancy of less than six months
- Plans for or significant possibility of pregnancy during the required follow-up window
- Significant cardiovascular surgery planned within six months following ICD implant
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 |
|---|---|---|
| Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position. | Device | Medtronic 4195 Active Fixation LV Lead, Medtronic passive fixation LV lead |
Primary outcome
Evidence of Change in Threshold of >1 Volt With Posture Changes
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- 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.
James B DeVille, M.D. principal investigator
Baylor Research Institute - The Heart Hospital Baylor Plano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead in people with Congestive Heart Failure, run by Baylor Research Institute 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 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: stopped early, as of the sponsor's last update on 26 May 2014. 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?
Yes. Results are posted in the registry (first posted 26 May 2014). 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?
Evidence of Change in Threshold of >1 Volt With Posture Changes (time frame: 6 months). 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 26 May 2014.