BAROSTIM THERAPY™ In Resistant Hypertension
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|ClinicalTrials.gov Identifier: NCT02880631|
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment|
|Hypertension||Device: BAROSTIM NEO™ System|
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.
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:
- 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
- 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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|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|
- 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.
- 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.
- 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.
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
|Contact: Elizabeth Galle||763-416-2876|
|Study Chair:||Hannes Reuter, PhD||Herzzentrum Uniklinik Köln|