Heart Failure, CongestiveNCT00541541
Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation
A study testing Phrenic nerve stimulation in people with Heart Failure, Congestive and Cardiac Pacing, Artificial, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
In this study, the investigators sought to determine whether a stimulation of the phrenic nerve affects heart function. Heart function is assessed by acoustic cardiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Cardiac Pacing, Artificial, Transcutaneous Electric Nerve Stimulation
- What is being tested?
- Phrenic nerve stimulation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2007to May 2012
- 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
- Patients following open heart surgery who need temporary pacing
Who cannot join
- Patients with permanent pacemakers
- Patients with fast changing need of vasopressor therapy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Luzern, Department of Cardiology
Lucerne, Canton of Lucerne, 6000
About this study
Official title: Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation Following Open Heart Surgery
In this study, the investigators sought to determine whether a stimulation of the phrenic nerve affects heart function. Heart function is assessed by acoustic cardiography.
Read the detailed description
Patients who need temporary pacing following open heart surgery and who are willing to participate receive a phrenic nerve electrode during the operation. Heart function is postoperatively assessed by acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA) during different forms of pacing (right ventricle, left ventricle, biventricular; AAI, DDD) and with or without phrenic nerve stimulation. Acoustic cardiography simultaneously integrates heart sounds and single-channel electrocardiography input to generate multiple parameters that correlate to established hemodynamic measures. Effects of phrenic nerve stimulation on heart function will be analyzed.
- Conditions
- Heart Failure, Congestive, Cardiac Pacing, Artificial, Transcutaneous Electric Nerve Stimulation
- Being tested
- Phrenic nerve stimulation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phrenic nerve stimulationProcedure or surgery
Patients receive a phrenic nerve stimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Collaborators
- Inovise Medical
- Responsible party
- Principal investigator, Prof. Paul Erne, Luzerner Kantonsspital
- Investigators
- Paul Erne, MD, Study chair, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541541
- Sponsor's protocol ID
- Audicor-Pacing
- Status last verified
- Apr 2013
- First submitted
- 8 Oct 2007
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation Following Open Heart Surgery
- ClinicalTrials.gov ID
- NCT00541541
- Acronym / sponsor ID
- Audicor-Pacing
- Conditions
- Heart Failure, Congestive, Cardiac Pacing, Artificial, Transcutaneous Electric Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Collaborators
- Inovise Medical
- Study start
- Feb 2007
- Primary completion
- May 2012 (actual)
- First posted
- 10 Oct 2007 (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.
In this study, the investigators sought to determine whether a stimulation of the phrenic nerve affects heart function. Heart function is assessed by acoustic cardiography.
Detailed description
Patients who need temporary pacing following open heart surgery and who are willing to participate receive a phrenic nerve electrode during the operation. Heart function is postoperatively assessed by acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA) during different forms of pacing (right ventricle, left ventricle, biventricular; AAI, DDD) and with or without phrenic nerve stimulation. Acoustic cardiography simultaneously integrates heart sounds and single-channel electrocardiography input to generate multiple parameters that correlate to established hemodynamic measures. Effects of phrenic nerve stimulation on heart function will be analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients following open heart surgery who need temporary pacing
Key exclusion criteria (2 listed)
- Patients with permanent pacemakers
- Patients with fast changing need of vasopressor therapy
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 |
|---|---|---|
| Phrenic nerve stimulationPatients receive a phrenic nerve stimulation | Procedure or surgery | – |
Primary outcome
Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing
Time frame: One day
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 17 Apr 2013.
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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.
Paul Erne, MD study chair
Luzerner Kantonsspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phrenic nerve stimulation in people with Heart Failure, Congestive and Cardiac Pacing, Artificial, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 1 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: finished, as of the sponsor's last update on 17 Apr 2013. 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 Switzerland. 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?
Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing (time frame: One day). 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 17 Apr 2013.