The Baroloop Study

NCT04981470 | Terminated Results DMC

• 1 other identifier: BL_CIP-FIH
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The baroloop Study is a non-randomized, prospective, single-arm, multi center First in Human (FIH) study with the primary objective being the assessment of the safety and feasibility of using the baroloop System in subjects with uncontrollable hypertension. The secondary objective is to document the effect of the baroloop device on the blood pressure and quality of life in subjects with hypertension. Up to 10 subjects will be enrolled in up to 3 sites in Europe.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Composite Major Adverse Event (MAE) Rate

  The MAE rate is calculated based on the number of participants that either died, were hospitalized for hypertensive crisis after the first titration visit, or experienced any device or procedure-related serious adverse events.

  at 6 months post-treatment

• Feasibility - Device Placement and Vagal Nerve Stimulation

  Feasibility was calculated based on the number of participants in whom the baroloop system was successfully placed around a vagal nerve and stimulation of the nerve was possible. Stimulation of the vagus nerve was attempted for the first time after either 14 or 21 days; depending on the healing progress of the participant after the surgery. Therefore, feasibility (ability to place the device and ability to stimulate the nerve after the surgery) was either confirmed after 14 days or 21 days, depending on the healing progress of the participant after the surgery.

  Day 14 or Day 21 post-implantation

Secondary Outcomes (6)

• Change in Blood Pressure

  at the time of implantation

• Change in 24-hour ABPM

  1, 3, 6, 12, 18 and 24 months

• Composite MAE Rate

  1, 3, 12, 18 and 24 months

• Change in Office Blood Pressure

  1, 3, 6, 12, 18 and 24 months

• Change in Antihypertensive Drugs/Dosages

  1, 3, 6, 12, 18 and 24 months

Study Arms (1)

Investigational Device

EXPERIMENTAL

Subjects implanted with the baroloop device

Device: baroloop System

Interventions

baroloop System DEVICE

vagal nerve stimulation

Investigational Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older and less than 80 years of age.
• 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 4 antihypertensive medicines consisting of a renin-angiotensin blocker(ACE) or Angiotensin II Receptor Blocker (ARBs), a calcium channel blocker (CCB), a diuretic and spironolactone for 4 weeks at treatment. If spironolactone is not tolerated, the regimen must include instead the addition of further diuretic therapy with either eplerenone, amiloride, higher-dose thiazide/thiazide-like diuretic or a loop diuretic, or the addition of bisoprolol or doxazosin. If none of these medicines are tolerated, then patients on a 3-drug regimen may be included.
• The Investigator has confirmed that the patient has already tried and/or is not suitable for treatment with currently CE-marked device-based therapies for resistant hypertension as an alternative to baroloop therapy.
• 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%).
• One or more episodes of orthostatic hypotension in the past year
• 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 or ejection fraction \< 30%), myocardial infarction, unstable angina, coronary bypass or coronary angioplasty during six (6) months prior to screening.

Sponsors & Collaborators

• neuroloop GmbH: lead
• Avania: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Affairs
• Organization: neuroloop

study@neuroloop.de

+497611543390

Study Officials

• Wilko Spiering

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 20, 2021
• First Posted: July 29, 2021
• Study Start: April 13, 2021
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-04

Locations

NL (1)