Clinical trial NCT02880631: BAROSTIM THERAPY™ In Resistant Hypertension
Official title: BAROSTIM THERAPY™ In Resistant Hypertension: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure Changes
timeFrame: Pre-implant baseline to 3 years post-implant
measure: Cardiovascular Medication Changes
timeFrame: Post-implant enrollment to 3 years post-implant
measure: Number of Health Care Utilizations
timeFrame: 3 months post-implant to 3 years post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Benjamin Franklin
city: Berlin
country: Germany
facility: Charité Campus Virchow
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
city: Cloppenburg
country: Germany
facility: Cloppenburg Katholische Kliniken Münsterland
city: Detmold
country: Germany
facility: Lippe Klinikum
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Erding
country: Germany
facility: Krankenhaus Erding
city: Frankfurt
country: Germany
facility: Cardiovascular Center 'CVC' Frankfurt
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: Göttingen
country: Germany
facility: Herzzentrum Göttingen
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hamm
country: Germany
facility: St. Barbara Klinik Hamm
city: Ingolstadt
country: Germany
facility: Kardiologie im Klinikum Ingolstadt
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Köln
country: Germany
facility: Universitätsklinikum Köln Herzzentrum
city: Lahr
country: Germany
facility: Herzentrum Lahr
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mainz
country: Germany
facility: Universitätsklinik Mainz
city: Papenburg
country: Germany
facility: Papenburg Marien Krankenhaus
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Siegen
country: Germany
facility: Marienkrankenhaus Siegen
city: Stadtlohn
country: Germany
facility: Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
city: Tuttlingen
country: Germany
facility: Klinikum Tuttlingen
city: Zwickau
country: Germany
facility: Heinrich-Braun Klinikum
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Herzzentrum Uniklinik Köln
name: Hannes Reuter, PhD
role: STUDY_CHAIR
References:
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.
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.
citation: 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.
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.