Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2016-12-13
2024-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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BAROSTIM NEO™ System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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CVRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Hannes Reuter, PhD
Role: STUDY_CHAIR
Herzzentrum Uniklinik Köln
Locations
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Charité Benjamin Franklin
Berlin, , Germany
Charité Campus Virchow
Berlin, , Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, , Germany
Cloppenburg Katholische Kliniken Münsterland
Cloppenburg, , Germany
Universitätsklinikum Köln Herzzentrum
Cologne, , 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
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, , Germany
Maastricht University Medical Center
Maastricht, , Netherlands
Countries
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Central Contacts
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Elizabeth Galle
Role: CONTACT
Facility Contacts
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References
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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.
Related Links
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BAROSTIM THERAPY website
Other Identifiers
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360051-001
Identifier Type: -
Identifier Source: org_study_id
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