Heart FailurePhase 2NCT02633644
Endovascular NeuromoDulation Treatment fOr Heart Failure Patients (ENDO-HF)
A Phase 2 study testing Harmony System in people with Heart Failure, run by Enopace Biomedical at 5 sites in 4 countries.
Trial summary
The purpose of the ENDO-HF study is to determine the safety \& performance of the Harmony System for the treatment of heart failure 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?
- Harmony System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Sep 2015to Jun 2023
- Phase
- Phase 2
- 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
- Subject is diagnosed as chronic heart failure NYHA class II-III
- Subject should be receiving optimal medical treatment
- Subject signed and dated informed consent
Who cannot join
- Subject has severe aortic sclerosis or calcification
- Subject diagnosed with severe aortic valve disease
- Subject has severe mitral stenosis
- Subject involved in any concurrent clinical investigation
- Subject with cerebral vascular accident or transient ischemic attack prior to enrollment
- Subject diagnosed with Marfan Syndrome
Show all 10Show fewer
- Subject with moderate or severe chronic obstructive lung disease
- Subject is allergic to iodine or contrast media
- Subject with prior cardiac transplant or heart transplant candidate
- Subject with a life expectancy of less than 12 months
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Israel2 sites
Rambam Healthcare Campus
Haifa, 3109601
Baruch Padeh Medical Center (Poriya)
Tiberias, 15208
About this study
Official title: The Harmony System for the Treatment of Heart Failure Patients - A Safety and Performance Study
The purpose of the ENDO-HF study is to determine the safety \& performance of the Harmony System for the treatment of heart failure
- Conditions
- Heart Failure
- Being tested
- Harmony System
- Keywords
- Heart Failure, Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmony SystemDevice
Percutaneous neuromodulation of the aortic wall
| Study group | Role | What they receive |
|---|---|---|
| Treated with Harmony System | Experimental | Implantation and activation of the Harmony endovascular neurostimulator Receives: Device: Harmony System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of all system and/or procedure related serious adverse events
Measured: 6 months
Secondary outcomes (8)
The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI)
Measured: 6 months
The change in the exercise capacity as defined in a 6-minute walk test
Measured: 6 months
The change in heart failure symptoms, as measured by quality of life, defined as an improvement from baseline on the Minnesota Living with Heart Failure® Questionnaire (MLWHFQ)
Measured: 6 months
The change in echocardiographic assessment of LV ejection fraction
Measured: 6 months
The change in echocardiographic assessment of LV end systolic volume
Measured: 6 months
The change in echocardiographic assessment of LV end diastolic volume
Measured: 6 months
The change in echocardiographic assessment of left atrium volume index
Measured: 6 months
The change in echocardiographic assessment of LV mass index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2023
Why it stopped: The company shut down
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enopace Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Weiss, MD, Study director, Enopace Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633644
- Sponsor's protocol ID
- CL-250
- Status last verified
- Jul 2023
- First submitted
- 15 Dec 2015
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Harmony System for the Treatment of Heart Failure Patients - A Safety and Performance Study
- ClinicalTrials.gov ID
- NCT02633644
- Acronym / sponsor ID
- CL-250
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiovascular Diseases, Heart Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The company shut down
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Enopace BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jun 2023 (actual)
- First posted
- 17 Dec 2015 (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 the ENDO-HF study is to determine the safety \& performance of the Harmony System for the treatment of heart failure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with Harmony System | Experimental | Device: Harmony SystemImplantation and activation of the Harmony endovascular neurostimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is diagnosed as chronic heart failure NYHA class II-III
- Subject should be receiving optimal medical treatment
- Subject signed and dated informed consent
Key exclusion criteria (10 listed)
- Subject has severe aortic sclerosis or calcification
- Subject diagnosed with severe aortic valve disease
- Subject has severe mitral stenosis
- Subject involved in any concurrent clinical investigation
- Subject with cerebral vascular accident or transient ischemic attack prior to enrollment
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 |
|---|---|---|
| Harmony SystemPercutaneous neuromodulation of the aortic wall | Device | Treated with Harmony System |
Primary outcome
The occurrence of all system and/or procedure related serious adverse events
Time frame: 6 months
8 secondary outcomes
The change in the New York Heart Association (NYHA) functional class as set by the Primary Investigator (PI)
Time frame: 6 months
The change in the exercise capacity as defined in a 6-minute walk test
Time frame: 6 months
The change in heart failure symptoms, as measured by quality of life, defined as an improvement from baseline on the Minnesota Living with Heart Failure® Questionnaire (MLWHFQ)
Time frame: 6 months
The change in echocardiographic assessment of LV ejection fraction
Time frame: 6 months
The change in echocardiographic assessment of LV end systolic volume
Time frame: 6 months
The change in echocardiographic assessment of LV end diastolic volume
Time frame: 6 months
The change in echocardiographic assessment of left atrium volume index
Time frame: 6 months
The change in echocardiographic assessment of LV mass index
Time frame: 6 months
Results and safety
The study was stopped early (reason given: The company shut down). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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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.
Daniel Weiss, MD study director
Enopace Biomedical
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Harmony System in people with Heart Failure, run by Enopace Biomedical at 5 sites in 4 countries.
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 10 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: stopped early, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel, Belgium, Croatia, Greece. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The company shut down). Results are not available in the source record.
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?
The occurrence of all system and/or procedure related serious adverse events (time frame: 6 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 28 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.