Heart Failure，CongestiveNCT03751904
Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
A study testing AcoustiCare in people with Heart Failure，Congestive, run by Signature Medical, Inc..
Trial summary
AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure，Congestive
- What is being tested?
- AcoustiCare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2019to 30 Mar 2019
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects between the ages of 18 - 80 years
- Willing and able to sign informed consent form
- Normal subjects without a history of heart disease who are recruited from the surrounding community
- Subjects with heart failure undergoing treatment in a hospital setting
Who cannot join
- Hemodynamic instability (Systolic BP>180 or <90 and Diastolic BP>90 and <60)
- Acute coronary syndrome
- Prior heart transplant recipients
- Subjects who are pacemaker dependent
- Severe obesity (body mass index > 40 kg/m2)
- Subjects who are pregnant
About this study
AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.
- Conditions
- Heart Failure，Congestive
- Being tested
- AcoustiCare
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcoustiCareDevice
Electronic stethoscope
| Study group | Role | What they receive |
|---|---|---|
| AcoustiCare | Other | Single Arm Receives: Device: AcoustiCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
The safety of the Acousticare device will be assessed by reviewing adverse events in all patients enrolled in the study
Measured: Subjects will be assessed for adverse events through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start25 Jan 2019
- Primary completion28 Feb 2019 (estimated)
- Study completion30 Mar 2019 (estimated)
Why it stopped: Sponsor is no longer pursuing the study.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Signature Medical, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751904
- Sponsor's protocol ID
- SIG-0001
- Status last verified
- Jan 2019
- First submitted
- 15 Nov 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
- ClinicalTrials.gov ID
- NCT03751904
- Acronym / sponsor ID
- SIG-0001
- Conditions
- Heart Failure，Congestive
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor is no longer pursuing the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Signature Medical, Inc.University, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 23 Nov 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.
AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AcoustiCare | Other | Device: AcoustiCareSingle Arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects between the ages of 18 - 80 years
- Willing and able to sign informed consent form
- Normal subjects without a history of heart disease who are recruited from the surrounding community
- Subjects with heart failure undergoing treatment in a hospital setting
Key exclusion criteria (6 listed)
- Hemodynamic instability (Systolic BP>180 or <90 and Diastolic BP>90 and <60)
- Acute coronary syndrome
- Prior heart transplant recipients
- Subjects who are pacemaker dependent
- Severe obesity (body mass index > 40 kg/m2)
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 |
|---|---|---|
| AcoustiCareElectronic stethoscope | Device | AcoustiCare |
Primary outcome
Incidence of Adverse Events
Time frame: Subjects will be assessed for adverse events through study completion, an average of 1 day
The safety of the Acousticare device will be assessed by reviewing adverse events in all patients enrolled in the study
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 29 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AcoustiCare in people with Heart Failure，Congestive, run by Signature Medical, Inc..
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 6 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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of Adverse Events (time frame: Subjects will be assessed for adverse events through study completion, an average of 1 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 29 Jan 2019.