NCT02880631

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
2 countries

26 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

December 13, 2016

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

7.6 years

First QC Date

August 15, 2016

Last Update Submit

April 18, 2023

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

BAROSTIM NEO™ SystemDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Charité Benjamin Franklin

Berlin, 12203, Germany

ACTIVE NOT RECRUITING

Charité Campus Virchow

Berlin, 13353, Germany

ACTIVE NOT RECRUITING

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Bernau, 16321, Germany

RECRUITING

Cloppenburg Katholische Kliniken Münsterland

Cloppenburg, 49661, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Köln Herzzentrum

Cologne, 50937, Germany

RECRUITING

Lippe Klinikum

Detmold, 32756, Germany

RECRUITING

Herzzentrum Dresden

Dresden, 01307, Germany

RECRUITING

Krankenhaus Erding

Erding, 85435, Germany

ACTIVE NOT RECRUITING

Cardiovascular Center 'CVC' Frankfurt

Frankfurt, 60398, Germany

RECRUITING

Universitätsklinikum Gießen und Marburg

Giessen, 35392, Germany

RECRUITING

Herzzentrum Göttingen

Göttingen, 37075, Germany

RECRUITING

Asklepios Klinik Altona

Hamburg, 22763, Germany

RECRUITING

St. Barbara Klinik Hamm

Hamm, 59073, Germany

ACTIVE NOT RECRUITING

Kardiologie im Klinikum Ingolstadt

Ingolstadt, 85049, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

RECRUITING

Herzentrum Lahr

Lahr, 77933, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Leipzig

Leipzig, 04109, Germany

RECRUITING

Universitätsklinik Mainz

Mainz, 55131, Germany

ACTIVE NOT RECRUITING

Papenburg Marien Krankenhaus

Papenburg, 26871, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

RECRUITING

Marienkrankenhaus Siegen

Siegen, 57072, Germany

RECRUITING

Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH

Stadtlohn, 48970, Germany

ACTIVE NOT RECRUITING

Klinikum Stuttgart

Stuttgart, 70174, Germany

RECRUITING

Klinikum Tuttlingen

Tuttlingen, 78532, Germany

RECRUITING

Heinrich-Braun Klinikum

Zwickau, 08060, Germany

ACTIVE NOT RECRUITING

Maastricht University Medical Center

Maastricht, 6229, Netherlands

ACTIVE NOT RECRUITING

Related Publications (4)

  • 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.

    PMID: 20883933BACKGROUND

  • 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.

    PMID: 21816315BACKGROUND

  • 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.

    PMID: 22341199BACKGROUND

  • 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.

    PMID: 22694986BACKGROUND

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Hannes Reuter, PhD

    Herzzentrum Uniklinik Köln

    STUDY CHAIR

Central Study Contacts

Elizabeth Galle

CONTACT

763-416-2876

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 26, 2016

Study Start

December 13, 2016

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)DE(25)