Baroloop Device for Resistant Hypertension

Baroloop Multicenter Trial (Baroloop MCT)

Recruiting N/A Interventional Study
Hypertension, Resistant to Conventional Therapy
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
neuroloop GmbH · Industry
Who this trial is looking for

This trial is looking for adults with high blood pressure that is hard to treat with medication. Participants will receive a device called the baroloop and will have regular clinic visits for monitoring and adjustments.

Are You a Good Fit for This Trial?
Must be taking Renin-angiotensin blockersCalcium channel blockersDiuretics
Rules you out Type 1 diabetesMorbid obesitySignificant heart failure

You may be able to join if

  • I am 18 years or older.
  • I have high blood pressure that isn't controlled with medication.
  • I have been on three specific blood pressure medications for at least 4 weeks.
  • I am willing to follow up with appointments and answer questions.
  • I have signed the consent form to participate.

You may not be able to join if

  • I have had an injury to my vagus nerve.
  • I have secondary causes of high blood pressure.
  • I have poorly controlled diabetes.
  • I require chronic oxygen therapy or have untreated sleep apnea.
  • I have a history of serious heart problems or stroke.
  • I have a pacemaker or implantable defibrillator.
  • I am pregnant.
  • I cannot participate effectively in follow-up due to other issues.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
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 wi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or older. 2. 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. 3. Mean 24-hour systolic ABPM ≥ 130 mm Hg and mean 24 hour d…
Contacts

Medical Scientific Affairs

+49 761 1543390

study@neuroloop.de

CONTACT