Trial Outcomes & Findings for The Baroloop Study (NCT NCT04981470)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

at 6 months post-treatment

Results posted on

2025-05-13

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Device Subjects implanted with the baroloop device baroloop System: vagal nerve stimulation
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational Device Subjects implanted with the baroloop device baroloop System: vagal nerve stimulation
Overall Study Device failure in all 4 patients	4

Baseline Characteristics

The Baroloop Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Device n=4 Participants Subjects implanted with the baroloop device baroloop System: vagal nerve stimulation
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment Netherlands	4 participants n=99 Participants

PRIMARY outcome

Timeframe: at 6 months post-treatment

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.

Outcome measures

Outcome measures
Measure	Investigational Device n=4 Participants Subjects implanted with the baroloop device baroloop System: vagal nerve stimulation
Composite Major Adverse Event (MAE) Rate	4 Participants

PRIMARY outcome

Timeframe: Day 14 or Day 21 post-implantation

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.

Outcome measures

Outcome measures
Measure	Investigational Device n=4 Participants Subjects implanted with the baroloop device baroloop System: vagal nerve stimulation
Feasibility - Device Placement and Vagal Nerve Stimulation	4 Participants

SECONDARY outcome

Timeframe: at the time of implantation

Change in blood pressure recorded during intraoperative stimulation

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Mean change of 24-hour ambulatory systolic and diastolic blood pressure post-treatment versus baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 3, 12, 18 and 24 months

he MAE consists of all causes of death, hospitalization for hypertensive crisis post-titration, and any device or procedure-related serious adverse events

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Mean change in office systolic and diastolic blood pressure

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Changes in antihypertensive drugs/dosages post-implantation as analyzed by Daily Defined Dosages (WHO Definition) and total medications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6, 12, 18 and 24 months

Quality of Life as measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Outcome measures

Outcome data not reported

Adverse Events

Investigational Device

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Investigational Device n=4 participants at risk Subjects implanted with the baroloop device baroloop System: vagal nerve stimulation
Surgical and medical procedures explantation surgery due to device failure	100.0% 4/4 • Number of events 4 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.

Other adverse events

Other adverse events
Measure	Investigational Device n=4 participants at risk Subjects implanted with the baroloop device baroloop System: vagal nerve stimulation
General disorders Dizziness after charging the device	25.0% 1/4 • Number of events 1 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.
General disorders Pressure on larynx	25.0% 1/4 • Number of events 1 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.
Surgical and medical procedures Reddening around chest wound after implant procedure	25.0% 1/4 • Number of events 1 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.
Infections and infestations Abscess left groin	25.0% 1/4 • Number of events 1 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.
Cardiac disorders Heart palpitations after medication increase	50.0% 2/4 • Number of events 2 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.
General disorders Dizziness	25.0% 1/4 • Number of events 1 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 1/4 • Number of events 1 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.
Infections and infestations Covid 19 infection	25.0% 1/4 • Number of events 1 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.
Musculoskeletal and connective tissue disorders Bursitis in left shoulder	25.0% 1/4 • Number of events 1 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.
Respiratory, thoracic and mediastinal disorders Chest pain, sensation of sickness, dyspnea	25.0% 1/4 • Number of events 1 • Adverse event data was collected for each patient until he or she left the study. As all patients exited the study due to device failure, the period of time AEs were collected varies from 95 to up to 598 days.

Additional Information

Clinical Affairs

neuroloop

Phone: +497611543390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place