Heart FailureSonR PilotNCT01287234
Atrio-Ventricular (AV) Delay Optimization Using Echocardiography Versus the SonR Signal
A study testing Echocardiogram/SonR in people with Heart Failure, run by Piedmont Healthcare at 1 site in United States.
Trial summary
The purpose of this study is to evaluate an external device (SonR sensor) that is capable of detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization therapy defibrillator (CRT-D) device may… 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?
- Echocardiogram/SonR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jul 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
- Implanted with any current Food and Drug Administration (FDA) approved CRT- D device and leads for 30 days or patients indicated for AV optimization
- ≥18 years of age
- Ability and willingness to provide written informed consent and HIPAA authorization
Who cannot join
- Chronic Atrial Fibrillation
- Heart Failure decompensation event within two weeks of enrollment
- Hypertrophic Obstructive Cardiomyopathy
- Patient currently enrolled in another ongoing clinical trial
- Pregnancy
- Less than 18 years of age
- Inability or unwillingness to provide written informed consent and HIPAA authorization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atrio-Ventricular Delay Optimization in Patients Implanted With a Cardiac Resynchronization Device Using Echocardiography Versus the SonR Signal: A Pilot Study
The purpose of this study is to evaluate an external device (SonR sensor) that is capable of detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization therapy defibrillator (CRT-D) device may be determined. The investigators will then compare the timing settings suggested by SonR to the settings suggested from the echocardiogram. The objective of this study is to determine if differences exist between these different methods of timing the contractions of the top and bottom chambers of the heart and if the SonR signal is able to produce results similar to those of an echocardiogram.
- Conditions
- Heart Failure
- Being tested
- Echocardiogram/SonR
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiogram/SonROther
All patients will have an echocardiograph and SonR sensor readings
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Other | All patients will have an echocardiogram and SonR sensor readings completed. Receives: Other: Echocardiogram/SonR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal blood flow method
To determine the best method of timing the contractions of the top and bottom chambers of the heart by using echocardiography versus using signals of the external SonR sensor.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- LivaNova
- Responsible party
- Sponsor
- Investigators
- Dan Dan, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287234
- Sponsor's protocol ID
- SonR Pilot
- Acronym
- SonR Pilot
- Status last verified
- Dec 2012
- First submitted
- 28 Jan 2011
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrio-Ventricular Delay Optimization in Patients Implanted With a Cardiac Resynchronization Device Using Echocardiography Versus the SonR Signal: A Pilot Study
- ClinicalTrials.gov ID
- NCT01287234
- Acronym / sponsor ID
- SonR Pilot / SonR Pilot
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Collaborators
- LivaNova
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Feb 2011 (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.
The purpose of this study is to evaluate an external device (SonR sensor) that is capable of detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization therapy defibrillator (CRT-D) device may be determined. The investigators will then compare the timing settings suggested by SonR to the settings suggested from the echocardiogram. The objective of this study is to determine if differences exist between these different methods of timing the contractions of the top and bottom chambers of the heart and if the SonR signal is able to produce results similar to those of an echocardiogram.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Other | Other: Echocardiogram/SonRAll patients will have an echocardiogram and SonR sensor readings completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Implanted with any current Food and Drug Administration (FDA) approved CRT- D device and leads for 30 days or patients indicated for AV optimization
- ≥18 years of age
- Ability and willingness to provide written informed consent and HIPAA authorization
Key exclusion criteria (7 listed)
- Chronic Atrial Fibrillation
- Heart Failure decompensation event within two weeks of enrollment
- Hypertrophic Obstructive Cardiomyopathy
- Patient currently enrolled in another ongoing clinical trial
- Pregnancy
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 |
|---|---|---|
| Echocardiogram/SonRAll patients will have an echocardiograph and SonR sensor readings | Other | All Patients |
Primary outcome
Optimal blood flow method
Time frame: 3 months
To determine the best method of timing the contractions of the top and bottom chambers of the heart by using echocardiography versus using signals of the external SonR sensor.
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 20 Dec 2012.
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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.
Dan Dan, MD principal investigator
Piedmont Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiogram/SonR in people with Heart Failure, run by Piedmont Healthcare 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 3 inclusion and 7 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 20 Dec 2012. 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?
Optimal blood flow method (time frame: 3 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 20 Dec 2012.