BAROSTIM THERAPY™ In Resistant Hypertension

Hypertension Clinical Trial

Official title:

BAROSTIM THERAPY™ In Resistant Hypertension: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02880631
• Other study ID #: 360051-001
• Status: Recruiting
• Start date: December 13, 2016
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: CVRx, Inc.
• Contact: Elizabeth Galle
• Phone: 763-416-2876
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• BAROSTIM NEO™ System

Locations

Country	Name	City	State
Germany	Charité Benjamin Franklin	Berlin
Germany	Charité Campus Virchow	Berlin
Germany	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau
Germany	Cloppenburg Katholische Kliniken Münsterland	Cloppenburg
Germany	Lippe Klinikum	Detmold
Germany	Herzzentrum Dresden	Dresden
Germany	Krankenhaus Erding	Erding
Germany	Cardiovascular Center 'CVC' Frankfurt	Frankfurt
Germany	Universitätsklinikum Gießen und Marburg	Gießen
Germany	Herzzentrum Göttingen	Göttingen
Germany	Asklepios Klinik Altona	Hamburg
Germany	St. Barbara Klinik Hamm	Hamm
Germany	Kardiologie im Klinikum Ingolstadt	Ingolstadt
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel
Germany	Universitätsklinikum Köln Herzzentrum	Köln
Germany	Herzentrum Lahr	Lahr
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitätsklinik Mainz	Mainz
Germany	Papenburg Marien Krankenhaus	Papenburg
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Marienkrankenhaus Siegen	Siegen
Germany	Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH	Stadtlohn
Germany	Klinikum Stuttgart	Stuttgart
Germany	Klinikum Tuttlingen	Tuttlingen
Germany	Heinrich-Braun Klinikum	Zwickau
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Countries where clinical trial is conducted

Germany,  Netherlands, 

References & Publications (4)

Bakris GL, Nadim MK, Haller H, Lovett EG, Schafer JE, Bisognano JD. Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. J Am Soc Hypertens. 2012 Mar-Apr;6(2):152-8. doi: 10.1016/j.jash.2012.01.003. Epub 2012 Feb 15. — View Citation

Bisognano JD, Bakris G, Nadim MK, Sanchez L, Kroon AA, Schafer J, de Leeuw PW, Sica DA. Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled rheos pivotal trial. J Am Coll Cardiol. 2011 Aug 9;58(7):765-73. doi: 10.1016/j.jacc.2011.06.008. — View Citation

Hoppe UC, Brandt MC, Wachter R, Beige J, Rump LC, Kroon AA, Cates AW, Lovett EG, Haller H. Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial. J Am Soc Hypertens. 2012 Jul-Aug;6(4):270-6. doi: 10.1016/j.jash.2012.04.004. Epub 2012 Jun 12. — View Citation

Scheffers IJ, Kroon AA, Schmidli J, Jordan J, Tordoir JJ, Mohaupt MG, Luft FC, Haller H, Menne J, Engeli S, Ceral J, Eckert S, Erglis A, Narkiewicz K, Philipp T, de Leeuw PW. Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol. 2010 Oct 5;56(15):1254-8. doi: 10.1016/j.jacc.2010.03.089. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Changes	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.	Pre-implant baseline to 3 years post-implant
Primary	Cardiovascular Medication Changes	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.	Post-implant enrollment to 3 years post-implant
Primary	Number of Health Care Utilizations	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.	3 months post-implant to 3 years post-implant