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BAROSTIM THERAPY™ In Resistant Hypertension

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ClinicalTrials.gov Identifier: NCT02880631
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Study Description
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Brief Summary:
The purpose of this registry (NCT02880631) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant hypertension.

Condition or disease Intervention/treatment
Hypertension Device: BAROSTIM NEO™ System

Detailed Description:

Summary:

The CVRx BAROSTIM THERAPY in Resistant Hypertension Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted. After 12 months, data may be obtained in six month intervals for up to three years after implant, at which time each subject will be exited from the registry.

Eligibility:

Subjects must sign an Ethics Committee (EC) approved informed consent form for the registry to participate.

Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension. These include:

  • Indications

    • Systolic blood pressure greater than or equal to 140 mmHg, and
    • Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications

  • Contraindications

    • Bilateral carotid bifurcations located above the level of the mandible
    • Baroreflex failure or autonomic neuropathy
    • Uncontrolled, symptomatic cardiac bradyarrhythmias
    • Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
    • Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: BAROSTIM THERAPY™ In Resistant Hypertension: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
Actual Study Start Date : December 13, 2016
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Blood Pressure Changes [ Time Frame: Pre-implant baseline to 3 years post-implant ]
    The results of an office cuff blood pressure measurement to be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.

  2. Cardiovascular Medication Changes [ Time Frame: Post-implant enrollment to 3 years post-implant ]
    Information on currently-utilized doses of cardiovascular medications will be collected at pre-implant baseline, 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.

  3. Number of Health Care Utilizations [ Time Frame: 3 months post-implant to 3 years post-implant ]
    Health care utilization information (e.g. heart failure hospitalizations) is collected at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension.
Criteria

Inclusion Criteria:

  • Has signed an EC approved informed consent form
  • Has been implanted with the BAROSTIM NEO system in the past 30 days
  • Systolic blood pressure greater than or equal to 140 mmHg, and
  • Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications

Exclusion Criteria:

  • Bilateral carotid bifurcations located above the level of the mandible
  • Baroreflex failure or autonomic neuropathy
  • Uncontrolled, symptomatic cardiac bradyarrhythmias
  • Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
  • Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880631


Contacts
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Contact: Elizabeth Galle 763-416-2876

Locations
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Sponsors and Collaborators
CVRx, Inc.
Investigators
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Study Chair: Hannes Reuter, PhD Herzzentrum Uniklinik Köln
More Information
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Additional Information:

Publications:

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Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT02880631    
Other Study ID Numbers: 360051-001
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases