BAROSTIM THERAPY™ In Resistant Hypertension

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Elizabeth Galle; Phone Number: 763-416-2876

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Active, not recruiting
    • Charité Benjamin Franklin
  • Berlin, Germany, 13353
    • Active, not recruiting
    • Charite Campus Virchow
  • Bernau, Germany, 16321
    • Recruiting
    • Immanuel Klinikum Bernau Herzzentrum Brandenburg
    • Contact: Daniela Bettin; Phone Number: +49 333 869 4604; Email: d.bettin@immanuel.de
    • Principal Investigator: Christian Butter
  • Cloppenburg, Germany, 49661
    • Active, not recruiting
    • Cloppenburg Katholische Kliniken Münsterland
  • Detmold, Germany, 32756
    • Recruiting
    • Lippe Klinikum
    • Contact: Angelika Göckeler; Phone Number: +49 5231 72 5727; Email: Angelika.Goeckeler@klinikum-lippe.de
    • Principal Investigator: Dirk Haertel
  • Dresden, Germany, 01307
    • Recruiting
    • Herzzentrum Dresden
    • Contact: Cornelia Fritz; Phone Number: +49 351 450 1332; Email: cornelia.fritz@tu-dresden.de
    • Principal Investigator: Robert Höllriegel
  • Erding, Germany, 85435
    • Active, not recruiting
    • Krankenhaus Erding
  • Frankfurt, Germany, 60398
    • Recruiting
    • Cardiovascular Center 'CVC' Frankfurt
    • Contact: Sabine De Bruijn; Phone Number: +49 69 97347653; Email: s.debruijn@cvcfrankfurt.de
  • Gießen, Germany, 35392
    • Recruiting
    • Universitätsklinikum Gießen und Marburg
  • Göttingen, Germany, 37075
    • Recruiting
    • Herzzentrum Gottingen
  • Hamburg, Germany, 22763
    • Recruiting
    • Asklepios Klinik Altona
    • Contact: Christine Neumann; Phone Number: +49401818818635; Email: chris.neumann@asklepios.com
  • Hamm, Germany, 59073
    • Active, not recruiting
    • St. Barbara Klinik Hamm
  • Ingolstadt, Germany, 85049
    • Recruiting
    • Kardiologie im Klinikum Ingolstadt
    • Contact: Kathrin Thiele; Phone Number: +49 841 880 2157; Email: Kathrin.Thiele@klinikum-ingolstadt.de
    • Principal Investigator: Steffen Christow
  • Kiel, Germany, 24105
    • Recruiting
    • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Contact: Anika Struve; Phone Number: +49 431 500 22915; Email: anika.struve@uksh.de
    • Principal Investigator: Hendrik Bonnemeier
  • Köln, Germany, 50937
    • Recruiting
    • Universitätsklinikum Köln Herzzentrum
    • Contact: Tatjana Schewior; Phone Number: +49 221 478 88273; Email: Tatjana.schewior@uk-koeln.de
  • Lahr, Germany, 77933
    • Active, not recruiting
    • Herzentrum Lahr
  • Leipzig, Germany, 04109
    • Recruiting
    • Universitätsklinikum Leipzig
    • Contact: Jenny Dietrich; Phone Number: +49 341 9712 408; Email: jenny.dietrich@medizin.uni-leipzig.de
    • Contact: Janine Starke; Phone Number: +49 (341) 97 12 443f; Email: janine.starke@medizin.uni-leipzig.de
    • Principal Investigator: Martin Neef
  • Mainz, Germany, 55131
    • Active, not recruiting
    • Universitatsklinik Mainz
  • Papenburg, Germany, 26871
    • Active, not recruiting
    • Papenburg Marien Krankenhaus
  • Regensburg, Germany, 93053
    • Recruiting
    • Universitätsklinikum Regensburg
    • Contact: Esther Keller; Phone Number: +49 941 944 7337; Email: Esther.Kellner@ukr.de
    • Principal Investigator: Marcus Fischer
  • Siegen, Germany, 57072
    • Recruiting
    • Marienkrankenhaus Siegen
    • Contact: Christoph Blanke; Phone Number: +49 2711 231 1215; Email: c.blanke@marienkrankenhaus.com
    • Principal Investigator: Michael Buerke
  • Stadtlohn, Germany, 48970
    • Active, not recruiting
    • Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH
  • Stuttgart, Germany, 70174
    • Recruiting
    • Klinikum Stuttgart
    • Contact: Simone Bohn; Phone Number: +49 0711 278-35301; Email: S.Bohn@klinikum-stuttgart.de
  • Tuttlingen, Germany, 78532
    • Recruiting
    • Klinikum Tuttlingen
  • Zwickau, Germany, 08060
    • Active, not recruiting
    • Heinrich-Braun Klinikum
• Netherlands
  • Maastricht, Netherlands, 6229
    • Active, not recruiting
    • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: CVRx, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2016
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 360051-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO