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
Qualifiers
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
Treatments tested in this trial
- baroloop system
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
neuroloop GmbH
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov