Congestive Heart FailureNCT02700191
Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial
A study testing uCor in people with Congestive Heart Failure, run by Zoll Medical Corporation.
Trial summary
Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be given the µ-Cor system to be added to their standard care, and randomized 1:1 to an interventional arm or a control arm. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- uCor
- 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
- 4 May 2016to Dec 2016
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women 20-90 years old.
- New York Heart Association (NYHA) class III-IV heart failure
- Followed by the Congestive Heart Failure (CHF) clinic in Nazareth
- Left ventricular ejection fraction <35%
- Requiring treatment with >40mg/day of furosemide* orally or with repeated bolus or intravenous infusion of furosemide* (*or equivalent bumetanide or torasemide).
Who cannot join
- Pregnancy
- Subjects who have received a heart transplant.
- Subjects who are unable or unwilling to follow the study requirements.
- Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
- Patients with skin breakdown in areas on the chest where device and electrode placement is required
About this study
Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be given the µ-Cor system to be added to their standard care, and randomized 1:1 to an interventional arm or a control arm.
- Conditions
- Congestive Heart Failure
- Being tested
- uCor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uCorDevice
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | For subjects in the Control arm, the parameters measured by the (µ-Cor) µ-Cor system will not be analysed or made available to the investigator. |
| uCor | Experimental | For subjects in the Interventional arm, all of the parameters measured by the (µ-Cor) µ-Cor system will be available to the investigator and will remain blinded to the subjects. The investigator will use µ-Cor information to aid in therapy adjustment decisions during the study period. Receives: Device: uCor |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of all-cause death or hospitalizations due to heart failure in the Interventional arm compared to the Control arm.
Measured: 30 days to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study start4 May 2016
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Lack of interest by Investigators
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700191
- Sponsor's protocol ID
- PCL-72-030
- Status last verified
- Aug 2020
- First submitted
- 2 Mar 2016
- Last updated
- 12 Aug 2020
- 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 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial
- ClinicalTrials.gov ID
- NCT02700191
- Acronym / sponsor ID
- PCL-72-030
- Conditions
- Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of interest by Investigators
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 May 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Mar 2016 (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.
Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be given the µ-Cor system to be added to their standard care, and randomized 1:1 to an interventional arm or a control arm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –For subjects in the Control arm, the parameters measured by the (µ-Cor) µ-Cor system will not be analysed or made available to the investigator. |
| uCor | Experimental | Device: uCorFor subjects in the Interventional arm, all of the parameters measured by the (µ-Cor) µ-Cor system will be available to the investigator and will remain blinded to the subjects. The investigator will use µ-Cor information to aid in therapy adjustment decisions during the study period. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women 20-90 years old.
- New York Heart Association (NYHA) class III-IV heart failure
- Followed by the Congestive Heart Failure (CHF) clinic in Nazareth
- Left ventricular ejection fraction <35%
- Requiring treatment with >40mg/day of furosemide* orally or with repeated bolus or intravenous infusion of furosemide* (*or equivalent bumetanide or torasemide).
Key exclusion criteria (5 listed)
- Pregnancy
- Subjects who have received a heart transplant.
- Subjects who are unable or unwilling to follow the study requirements.
- Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
- Patients with skin breakdown in areas on the chest where device and electrode placement is required
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 |
|---|---|---|
| uCor | Device | uCor |
Primary outcome
composite of all-cause death or hospitalizations due to heart failure in the Interventional arm compared to the Control arm.
Time frame: 30 days to 3 months
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 12 Aug 2020.
- 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.
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 uCor in people with Congestive Heart Failure, run by Zoll Medical Corporation.
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 5 inclusion and 5 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 12 Aug 2020. 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?
composite of all-cause death or hospitalizations due to heart failure in the Interventional arm compared to the Control arm. (time frame: 30 days to 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 12 Aug 2020; AzTrials last refreshed its copy on 29 Oct 2026.