Baroloop Multicenter Trial (Baroloop MCT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsorneuroloop GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
baroloop system
DeviceParticipants will have the baroloop device implanted for selective stimulation of the vagus nerve.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
6 months after initial stimulation2
Performance
Change in mean 24-hour Systolic Ambulatory Blood Pressure (ABP) by ambulatory blood pressure monitoring
Time frame
6 months after initial stimulationSponsors and contacts
Click on the lead sponsor to view all of their trials.
neuroloop GmbH
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov