UK Registry for Baroreflex Activation Therapy

NCT03730519 | Terminated

• 1 other identifier: MCPG1M8R
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a post-marketing open label single arm, single centre clinical trial of electrical carotid sinus stimulation with the Barostim Neo device to target sub-optimally controlled arterial hypertension or highly variable blood pressure in patients for whom no alternative therapies are available.

Conditions

Baroreflex Failure Syndrome; Hypertension, Resistant to Conventional Therapy

Keywords

Refractory Hypertension

Outcome Measures

Primary Outcomes (3)

• Ambulatory Systolic & Diastolic Blood Pressure changes in patients with uncontrolled (refractory) hypertension

  6 months

• Ambulatory Systolic & Diastolic Blood Pressure variability change in patients with highly variable BP due to baroreflex failure

  6 months

• Incidence of Treatment-Emergent Adverse Events in both groups of patients

  6 months

Secondary Outcomes (2)

• Change in European Quality of Life 5 dimension (Eq-5D) score in both groups of patients

  6 months

• Changes in autonomic indices in both groups of patients

  6 months

Other Outcomes (3)

• Change in echocardiographic left ventricular mass in both groups of patients

  6 months

• Change in pulse wave velocity in both groups of patients

  6 months

• Change in antihypertensive whole medicine equivalent in both groups of patients

  6 months

Study Arms (2)

Patients with refractory hypertension

ACTIVE COMPARATOR

Patients with refractory hypertension which cannot be controlled with drug therapy in the hands of hypertension specialists will be treated with Baroreflex Activation Therapy with Barostim Neo and followed up for a period of up to 3 years

Device: Baroreflex Activation Therapy with Barostim Neo

Patients with highly variable BP

ACTIVE COMPARATOR

Patients with symptomatic highly variable blood pressure due to afferent baroreceptor failure which cannot be controlled with drug therapy in the hands of hypertension specialists will be treated with Baroreflex Activation Therapy with Barostim Neo and followed up for a period of up to 3 years

Device: Baroreflex Activation Therapy with Barostim Neo

Interventions

Baroreflex Activation Therapy with Barostim Neo DEVICE

Baroreflex activation therapy (BAT) delivers electrical field stimulation at the carotid sinus to lower BP.

Also known as: Electrical Carotid sinus stimulation

Patients with highly variable BP; Patients with refractory hypertension

Eligibility Criteria

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

You may qualify if:

• Patients will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol restrictions.
• The study subjects will be either:
• I. Refractory hypertensive patients (daytime systolic ambulatory BP (ABP) \> 150 mmHg) in whom all pharmacological approaches to control BP have failed or were intolerable.
• or II. Symptomatic patients with exaggerated BPV documented on daytime ABP monitoring (SD \>18 mmHg) who cannot achieve effective BP control with pharmacological approaches
• For BPV group, evidence of peripheral baroreflex dysfunction as determined by non-invasive autonomic function testing
• Patients will have been established on a stable antihypertensive treatment regime for at least 1 month by the time of participation in the study and changes in pharmacological intervention for the duration of the trial are to be avoided unless clinically mandated.

You may not qualify if:

• HTN secondary to an identifiable and treatable cause
• Carotid atherosclerosis determined by ultrasound or angiographic evaluation greater than 50% stenosis
• Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
• Bifurcation of the carotid on the side planned needs to be below level of mandible by ultrasound
• Uncontrolled, symptomatic cardiac bradyarrhythmias.
• Myocardial infarction, unstable angina or cerebral vascular accident within 3 months before implant.
• Clinically significant cardiac valvular disease
• Prior implant in the carotid sinus region,
• Currently implanted electrical medical devices,
• End stage renal (with eGFR \<15 mL/min) or liver disease
• Pregnancy or contemplating pregnancy.
• BMI \> 40 kg/sq m
• Inability to tolerate ambulatory blood pressure monitoring
• Patient with other co-morbidity likely to have life expectancy \<3y
• Systolic left heart failure with ejection fraction \<40%

Sponsors & Collaborators

• Queen Mary University of London: lead
• CVRx, Inc.: collaborator

Study Sites (1)

William Harvey Research Institute

London, EC1M 6BQ, United Kingdom

Location

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Melvin D Lobo, MBChB PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a post-marketing open label twin arm, single centre clinical trial of electrical carotid sinus stimulation with the Barostim Neo device to target sub-optimally controlled arterial hypertension or highly variable blood pressure in patients for whom no alternative therapies are available.

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 5, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

GB (1)