Hypertension
Conditions
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.
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
Interventions
DEVICEBAROSTIM NEO™ System
Sponsors
CVRx, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Changes | 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. |
| Cardiovascular Medication Changes | 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. |
| Number of Health Care Utilizations | 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. |
Countries
Germany, Netherlands
Contacts
CONTACTNicole Baumann
STUDY_CHAIRHannes Reuter, PhD
Herzzentrum Uniklinik Köln
Outcome results
None listed