Baroloop Multicenter Trial (Baroloop MCT)

NCT06518915 | Recruiting

• 1 other identifier: BL_MCT-CIP
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 4

Brief 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 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.

Conditions

Hypertension, Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (2)

• 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

  6 months after initial stimulation

• Performance

  Change in mean 24-hour Systolic Ambulatory Blood Pressure (ABP) by ambulatory blood pressure monitoring

  6 months after initial stimulation

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Implantation of the baroloop device

Device: baroloop system

Interventions

baroloop system DEVICE

Participants will have the baroloop device implanted for selective stimulation of the vagus nerve.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• neuroloop GmbH: lead
• Avania: collaborator

Study Sites (4)

Clemenshospital Münster

Münster, North Rhine-Westphalia, 48153, Germany

RECRUITING

Marienhaus Klinikum Mainz

Mainz, Rhineland-Westphalia, 55131, Germany

RECRUITING

Städtisches Klinikum Dresden

Dresden, Saxony, 01067, Germany

RECRUITING

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Central Study Contacts

Medical Scientific Affairs

CONTACT

+49 761 1543390; study@neuroloop.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: May 22, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

DE (3); NL (1)