Hypertension, Resistant to Conventional TherapyNCT06518915
Baroloop Multicenter Trial (Baroloop MCT)
A study testing baroloop system in people with Hypertension, Resistant to Conventional Therapy, run by neuroloop GmbH at 4 sites in 2 countries.
Trial summary
The goal of this clinical trial is to learn weather the baroloop system is safe and works to treat hypertension in adults that do not respond sufficiently to medication. The main questions it aims to answer are: Is the baroloop device associated with any major medical problems including death? Does the baroloop lower… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- baroloop system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 22 May 2024to 1 Oct 2026
- 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
- Aged 18 years or older.
- Persistent office systolic blood pressure (SBP) ≥ 140 mm Hg and diastolic blood pressure (DBP) > 90 mm Hg on antihypertensive medicines on two visits separated by a minimum of four weeks.
- Mean 24-hour systolic ABPM ≥ 130 mm Hg and mean 24 hour diastolic ABPM ≥ 80 mm Hg conducted after direct observed therapy to confirm that antihypertensive medicines were taken as prescribed during the ABPM measurement.
- Stable drug regimen of 3 antihypertensive medicines consisting of a reninangiotensin blocker (ACE) or Angiotensin II Receptor Blocker (ARBs), a calcium channel blocker (CCB), and a diuretic for 4 weeks at treatment.
- Willingness and ability to comply with follow-up requirements.
- Signed informed consent.
Who cannot join
- Any patient in whom access to the vagal nerve is limited by the size of the vagus (a size not compatible with the baroloop cuff).
- Any patient with a history of injury to the vagus nerve or its branches (e.g., the recurrent laryngeal nerve).
- Secondary causes of hypertension.
- Calculated eGFR < 30 mL/min/1.73m2.
- Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c > 10%).
- Requirement for chronic oxygen therapy or mechanical ventilation.
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- Untreated (no CPAP therapy) sleep apnea (AHI > 15)
- Morbid obesity, defined as Body Mass Index >40 kg/m2 or arm circumference 46 cm.
- Pacemaker and/or implantable defibrillators.
- History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening.
- Symptomatic carotid artery disease or > 70% occlusion of either carotid artery; any carotid malformation or lesion, a carotid bruit or other abnormal carotid sound.
- Prior surgery, radiation therapy or scarring in the neck in the region of the carotid artery (e.g., patients with a tracheostomy, extensive thymectomy or thyroid surgery).
- Limited mobility of the neck secondary to vertebral disease or prior vertebral surgery, including patients who wear a cervical support.
- History of heart failure (NYHA class III-IV).
- Cardiac arrythmias (atrial fibrillation, atrial flutter, etc.) that require anticoagulation if the condition interferes with a consistent measurement of blood pressure.
- Unexplained syncope in the last 6 months.
- History of bleeding disorders, thrombocytopenia, hemophilia, or significant anemia (hemoglobin (Hgb) < 10 g/dl).
- Current anticoagulation therapy (excluding antiplatelet therapy with aspirin as a sole therapy).
- History of unresolved drug or alcohol use.
- Active treatment of a psychiatric ailment.
- Life expectancy of less than 12 months due to other disease.
- Subject has a condition that, in the opinion of the investigator, precludes participation, including willingness to comply, with all follow-up procedures.
- Participation in another clinical study for which follow-up is currently on-going.
- Women who are pregnant
- Resting heart rateof < 45 beats/min s, confirmed at both baseline visits.
- Baroreflex failure or autonomic neuropathy
- Symptomatic, uncontrolled bradyarrhythmias
- Atrioventricular block of any grade
- Presence of a vagus stimulator
- Patients who are likely to require magnetic resonance imaging (MRI) of the cervical area
- Occupational exposure to high levels of non-ionizing radiation that may interfere with therapy
- Patients with a limited ability to read, understand and execute adjustment procedures (for example, persons suffering from dementia).
- Likely exposure to diathermy.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Städtisches Klinikum Dresden
Dresden, Saxony, 01067
Marienhaus Klinikum Mainz
Mainz, Rhineland-Westphalia, 55131
Clemenshospital Münster
Münster, North Rhine-Westphalia, 48153
About this study
Official title: Baroloop MCT - A Multicenter Trial of Safety and Performance of Baroloop
The goal of this clinical trial is to learn weather the baroloop system is safe and works to treat hypertension in adults that do not respond sufficiently to medication. The main questions it aims to answer are:
- Is the baroloop device associated with any major medical problems including death?
- Does the baroloop lower the blood pressure of study participants?
Participants will be implanted with the baroloop device. Afterwards they will visit the clinic after 14 days, 3 months, 6 months, 12 months, 18 months, and 24 months for adjustment of the device settings and/or other study related assessments. Participants will also be asked to answer questions regarding their quality of life.
- Being tested
- baroloop system
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baroloop systemDevice
Participants will have the baroloop device implanted for selective stimulation of the vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Implantation of the baroloop device Receives: Device: baroloop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the baroloop device
Composite Major Adverse Event (MAE) Rate including all-causes of death and all device or procedure-related serious adverse event
Measured: 6 months after initial stimulation
Performance
Change in mean 24-hour Systolic Ambulatory Blood Pressure (ABP) by ambulatory blood pressure monitoring
Measured: 6 months after initial stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start22 May 2024
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Why it stopped: Terminated following a device deficiency in 1 subject. Benefit-risk and development assessments did not support continuation within the planned framework. Root cause analysis pending.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- neuroloop GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518915
- Sponsor's protocol ID
- BL_MCT-CIP
- Status last verified
- Oct 2026
- First submitted
- 19 Jul 2024
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baroloop MCT - A Multicenter Trial of Safety and Performance of Baroloop
- ClinicalTrials.gov ID
- NCT06518915
- Acronym / sponsor ID
- BL_MCT-CIP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated following a device deficiency in 1 subject. Benefit-risk and development assessments did not support continuation within the planned framework. Root cause analysis pending.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- neuroloop GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 22 May 2024 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 25 Jul 2024 (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.
The goal of this clinical trial is to learn weather the baroloop system is safe and works to treat hypertension in adults that do not respond sufficiently to medication. The main questions it aims to answer are:
- Is the baroloop device associated with any major medical problems including death?
- Does the baroloop lower the blood pressure of study participants?
Participants will be implanted with the baroloop device. Afterwards they will visit the clinic after 14 days, 3 months, 6 months, 12 months, 18 months, and 24 months for adjustment of the device settings and/or other study related assessments. Participants will also be asked to answer questions regarding their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: baroloop systemImplantation of the baroloop device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older.
- Persistent office systolic blood pressure (SBP) ≥ 140 mm Hg and diastolic blood pressure (DBP) > 90 mm Hg on antihypertensive medicines on two visits separated by a minimum of four weeks.
- Mean 24-hour systolic ABPM ≥ 130 mm Hg and mean 24 hour diastolic ABPM ≥ 80 mm Hg conducted after direct observed therapy to confirm that antihypertensive medicines were taken as prescribed during the ABPM measurement.
- Stable drug regimen of 3 antihypertensive medicines consisting of a reninangiotensin blocker (ACE) or Angiotensin II Receptor Blocker (ARBs), a calcium channel blocker (CCB), and a diuretic for 4 weeks at treatment.
- Willingness and ability to comply with follow-up requirements.
Key exclusion criteria (33 listed)
- Any patient in whom access to the vagal nerve is limited by the size of the vagus (a size not compatible with the baroloop cuff).
- Any patient with a history of injury to the vagus nerve or its branches (e.g., the recurrent laryngeal nerve).
- Secondary causes of hypertension.
- Calculated eGFR < 30 mL/min/1.73m2.
- Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c > 10%).
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 |
|---|---|---|
| baroloop systemParticipants will have the baroloop device implanted for selective stimulation of the vagus nerve. | Device | Treatment Arm |
Primary outcome
Safety of the baroloop device
Time frame: 6 months after initial stimulation
Composite Major Adverse Event (MAE) Rate including all-causes of death and all device or procedure-related serious adverse event
Performance
Time frame: 6 months after initial stimulation
Change in mean 24-hour Systolic Ambulatory Blood Pressure (ABP) by ambulatory blood pressure monitoring
Results and safety
The study was stopped early (reason given: Terminated following a device deficiency in 1 subject. Benefit-risk and development assessments did not support continuation within the planned framework. Root cause analysis pending.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing baroloop system in people with Hypertension, Resistant to Conventional Therapy, run by neuroloop GmbH at 4 sites in 2 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 6 inclusion and 33 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands. 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 was stopped early (reason given: Terminated following a device deficiency in 1 subject. Benefit-risk and development assessments did not support continuation within the planned framework. Root cause analysis pending.). 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?
Safety of the baroloop device (time frame: 6 months after initial stimulation). The study lists 2 primary outcomes in all. 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 Oct 2026.