BAROSTIM THERAPY™ In Resistant Hypertension

Recruiting

• Conditions: Hypertension

• Registration Number: NCT02880631
• Lead Sponsor: CVRx, Inc.

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

Study Timeline

• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Study Start: 2016-12-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (26)

Charité Benjamin Franklin; 🇩🇪 Berlin, Germany

Charité Campus Virchow; 🇩🇪 Berlin, Germany

Cardiovascular Center 'CVC' Frankfurt; 🇩🇪 Frankfurt, Germany

Krankenhaus Erding; 🇩🇪 Erding, Germany

Cloppenburg Katholische Kliniken Münsterland; 🇩🇪 Cloppenburg, Germany

Lippe Klinikum; 🇩🇪 Detmold, Germany

Universitätsklinikum Gießen und Marburg; 🇩🇪 Gießen, Germany

Universitätsklinik Mainz; 🇩🇪 Mainz, Germany

Immanuel Klinikum Bernau Herzzentrum Brandenburg; 🇩🇪 Bernau, Germany

St. Barbara Klinik Hamm; 🇩🇪 Hamm, Germany

Herzzentrum Göttingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel; 🇩🇪 Kiel, Germany

Heinrich-Braun Klinikum; 🇩🇪 Zwickau, Germany

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

Herzentrum Lahr; 🇩🇪 Lahr, Germany

Kardiologie im Klinikum Ingolstadt; 🇩🇪 Ingolstadt, Germany

Universitätsklinikum Köln Herzzentrum; 🇩🇪 Köln, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum Regensburg; 🇩🇪 Regensburg, Germany

Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH; 🇩🇪 Stadtlohn, Germany

Klinikum Stuttgart; 🇩🇪 Stuttgart, Germany

Klinikum Tuttlingen; 🇩🇪 Tuttlingen, Germany

Papenburg Marien Krankenhaus; 🇩🇪 Papenburg, Germany

Marienkrankenhaus Siegen; 🇩🇪 Siegen, Germany

Herzzentrum Dresden; 🇩🇪 Dresden, Germany

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands