Left Ventricular Assist DevicePWA-HFNCT01642927
Pulse Wave Analysis in Advanced Heart Failure
An observational study of Left Ventricular Assist Device and Heart Failure, run by University of Minnesota at 1 site in United States.
Trial summary
A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Assist Device, Heart Failure, Intra-aortic Balloon Pump
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2016
- 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: Advanced heart failure patients, eligible for or currently treated with LVAD, outpatient cardiology clinic or inpatient heart failure service patients
Who may be able to join
- 1)18 years of age or older
- 2)Advanced heart failure as defined by need for IABP or LVAD
- 3)One or more of the following:
- Current inpatient heart failure treatment with intra-aortic balloon pump (IABP)-IABP Group
- •≤ 1 week post-LVAD implantation with current IABP support-IABP/LVAD Group
- •≥ 3 mo post-LVAD placement and scheduled for LVAD speed optimization with echocardiography.-Post-LVAD Group
- Post-LVAD placement with suspected GI hemorrhage or LVAD thrombosis-LVAD Event Group
- 4)Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- Clinical status will not permit pause of IABP (IABP and IABP/LVAD Groups)
- Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group)
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Minnesota Lillehei Heart Institute
Minneapolis, Minnesota, 55455
About this study
Official title: Pulse Wave Analysis in Advanced Heart Failure Patients Before and After Ventricular Assist Device
A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.
Read the detailed description
Pulse waveforms, especially central pressure waveforms, are predictive of cardiovascular events. Peripheral waveforms have been correlated to central waveforms. Peripheral waveforms can be easily measured through applanation tonometry. In this study the investigators hypothesize:
- That previously established peripheral tonometry techniques would apply to patients with advanced heart failure, including continuous flow LVADs and facilitate serial evaluation of central hemodynamics without invasive monitoring.
- That temporary changes in LVAD speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms.
- That clinical events involving LVAD will have characteristic frequency spectra.
- Conditions
- Left Ventricular Assist Device, Heart Failure, Intra-aortic Balloon Pump, LVAD Clot, LVAD-related GI Bleed
- Keywords
- LVAD, IABP, Heart Failure, Thrombosis, Hemorrhage
- Medical subject headings
- Heart Failure, Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intra-Aortic Balloon Pump (IABP) Group | Advanced Heart Failure and/or pre-LVAD surgical patient with IABP | |
| IABP/LVAD Group | Post-LVAD surgical patients with IABP | |
| Post-LVAD Group | LVAD patients 3 months or greater post-implantation undergoing echocardiography | |
| LVAD Event Group | LVAD patients who have developed LVAD thrombosis or GI hemorrhage related to LVAD | |
| Arrhythmia group | LVAD patient with an irregular heartbeat. | |
| Valvular disease group | LVAD patient with valvular heart disease | |
| Normal control group | Healthy participant without any known heart disease (Control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of pulse wave signatures in LVAD patients
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: PI left University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Assist DeviceStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Eckman, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642927
- Sponsor's protocol ID
- FWA00000312-7
- Acronym
- PWA-HF
- Status last verified
- Apr 2023
- First submitted
- 12 Jul 2012
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Wave Analysis in Advanced Heart Failure Patients Before and After Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT01642927
- Acronym / sponsor ID
- PWA-HF / FWA00000312-7
- Conditions
- Left Ventricular Assist Device, Heart Failure, Intra-aortic Balloon Pump, LVAD Clot, LVAD-related GI Bleed
- Keywords
- LVAD, IABP, Heart Failure, Thrombosis, Hemorrhage
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Jul 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.
A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.
Detailed description
Pulse waveforms, especially central pressure waveforms, are predictive of cardiovascular events. Peripheral waveforms have been correlated to central waveforms. Peripheral waveforms can be easily measured through applanation tonometry. In this study the investigators hypothesize:
- That previously established peripheral tonometry techniques would apply to patients with advanced heart failure, including continuous flow LVADs and facilitate serial evaluation of central hemodynamics without invasive monitoring.
- That temporary changes in LVAD speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms.
- That clinical events involving LVAD will have characteristic frequency spectra.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Intra-Aortic Balloon Pump (IABP) Group | – | –Advanced Heart Failure and/or pre-LVAD surgical patient with IABP |
| IABP/LVAD Group | – | –Post-LVAD surgical patients with IABP |
| Post-LVAD Group | – | –LVAD patients 3 months or greater post-implantation undergoing echocardiography |
| LVAD Event Group | – | –LVAD patients who have developed LVAD thrombosis or GI hemorrhage related to LVAD |
| Arrhythmia group | – | –LVAD patient with an irregular heartbeat. |
| Valvular disease group | – | –LVAD patient with valvular heart disease |
| Normal control group | – | –Healthy participant without any known heart disease (Control group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced heart failure patients, eligible for or currently treated with LVAD, outpatient cardiology clinic or inpatient heart failure service patients
Key inclusion criteria (8 listed)
- 1)18 years of age or older
- 2)Advanced heart failure as defined by need for IABP or LVAD
- Current inpatient heart failure treatment with intra-aortic balloon pump (IABP)-IABP Group
- •≤ 1 week post-LVAD implantation with current IABP support-IABP/LVAD Group
- •≥ 3 mo post-LVAD placement and scheduled for LVAD speed optimization with echocardiography.-Post-LVAD Group
Key exclusion criteria (2 listed)
- Clinical status will not permit pause of IABP (IABP and IABP/LVAD Groups)
- Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observation of pulse wave signatures in LVAD patients
Time frame: ongoing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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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.
Peter Eckman, MD principal investigator
University of Minnesota
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 Left Ventricular Assist Device and Heart Failure, run by University of Minnesota 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 8 inclusion and 2 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: withdrawn, as of the sponsor's last update on 7 Apr 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Observation of pulse wave signatures in LVAD patients (time frame: ongoing). 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 7 Apr 2023.