Heart Failure, SystolicImpelNCT03640000
Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy
A study testing Impedance measurements in Cardiac Resynchronization therapy in people with Heart Failure, Systolic, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study aims at Optimizing measured parameters to reflect underlying pathology in dyssynchronous hearts. This is an experimental study in patients were bioimpedance measurements are performed during implantation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Impedance measurements in Cardiac Resynchronization therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to Dec 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Indication for Cardiac resynchronization therapy or Upgrade of exciting Device according to the current European Society of Cardiology guidelines.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0027
Hans Henrik Odland, hodland@ous-hf.no
About this study
Official title: Acute Changes in Bioimpedance During Cardia Resynchronization Therapy
This study aims at Optimizing measured parameters to reflect underlying pathology in dyssynchronous hearts. This is an experimental study in patients were bioimpedance measurements are performed during implantation.
Read the detailed description
Patients who are eligible for implantation af a Cardiac Resynchronization Therapy Device according to European Society of Cardiology guidelines are included. Measurements are performed on implanted leads and stored for post Processing. The study entry ends for each patient With completion of the implantation procedure.
- Conditions
- Heart Failure, Systolic
- Being tested
- Impedance measurements in Cardiac Resynchronization therapy
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impedance measurements in Cardiac Resynchronization therapyDiagnostic test
Bioimpedance measurements
| Study group | Role | What they receive |
|---|---|---|
| Determination of impedance signals | Experimental | This single arm study is designed to measure impedance signals from implanted leads in different positions in the heart. Signals obtained at different pre specified position are compared to each other to determine the robustness of the acquired measurements. Receives: Diagnostic Test: Impedance measurements in Cardiac Resynchronization therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimization of Bioimpedance measurements
Acquisition of absolute and imaginary bioimpedance signals from electrodes of known location within the heart at different input current frequencies. Pacing is performed from Three different electrodes during acquisition of bioimpedance acquisition forming Three different groups. Wavelets of the signals are analyzed within each Group and compared within the Group and between the Groups. Optimization is achived when a discrimination factor that is calculated is improved.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startJan 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Henrik Odland, Oslo University Hospital
- Investigators
- Hans Henrik Odland, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640000
- Sponsor's protocol ID
- 2014/1223
- Acronym
- Impel
- Status last verified
- Aug 2018
- First submitted
- 30 Oct 2016
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Changes in Bioimpedance During Cardia Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT03640000
- Acronym / sponsor ID
- Impel / 2014/1223
- Conditions
- Heart Failure, Systolic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Aug 2018 (actual)
- 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 aims at Optimizing measured parameters to reflect underlying pathology in dyssynchronous hearts. This is an experimental study in patients were bioimpedance measurements are performed during implantation.
Detailed description
Patients who are eligible for implantation af a Cardiac Resynchronization Therapy Device according to European Society of Cardiology guidelines are included. Measurements are performed on implanted leads and stored for post Processing. The study entry ends for each patient With completion of the implantation procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Determination of impedance signals | Experimental | Diagnostic Test: Impedance measurements in Cardiac Resynchronization therapyThis single arm study is designed to measure impedance signals from implanted leads in different positions in the heart. Signals obtained at different pre specified position are compared to each other to determine the robustness of the acquired measurements. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Impedance measurements in Cardiac Resynchronization therapyBioimpedance measurements | Diagnostic test | Determination of impedance signals |
Primary outcome
Optimization of Bioimpedance measurements
Time frame: 3 years
Acquisition of absolute and imaginary bioimpedance signals from electrodes of known location within the heart at different input current frequencies. Pacing is performed from Three different electrodes during acquisition of bioimpedance acquisition forming Three different groups. Wavelets of the signals are analyzed within each Group and compared within the Group and between the Groups. Optimization is achived when a discrimination factor that is calculated is improved.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Hans Henrik Odland, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impedance measurements in Cardiac Resynchronization therapy in people with Heart Failure, Systolic, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 21 Aug 2018. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hans Henrik Odland, MD, PhD (23070000 ext. +47, h.h.odland@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimization of Bioimpedance measurements (time frame: 3 years). 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 21 Aug 2018.