Trial document




drksid header

  DRKS00009388

Trial Description

start of 1:1-Block title

Title

Barostim Therapy™ in Heart Failure with Preserved Ejection Fraction:
A Data Collection Registry with the CE-Marked Barostim neo™ System

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

HFpEF Registry

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this registry is to evaluate the CE-marked Barostim Therapy in patients with Hypertension and Heartfailure.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The purpose of this registry is to evaluate Barostim Therapy with the Barostim Neo system in subjects implanted under the CE Marked indication for resistant hypertension and who also have evidence of heart failure with preserved ejection fraction (HFpEF).

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009388
  •   2015/09/22
  •   2016/08/23
  •   no
  •   Approved
  •   6776, Ethikkommission der Medizinischen Hochschule Hannover
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   ClinicalTrials.gov  (NCT02876042 )
  •   360047  (Protokoll Nr.)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I50.9 -  Heart failure, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Post-market registry study in patients with Barostim therapy and preserved ejection fraction: heart failure and device data will be collected after 3 and 6 months, which are compared with the values at baseline (before Barostim therapy)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

To describe change in office cuff systolic blood pressure at 6 months compared to pre-implant baseline.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

To describe changes in the following measures at 6 months compared to pre-implant baseline:
• Left ventricular mass index
• LA volume index
• E/E’ ratio
• Other echocardiographic measures
To describe changes in the following measures at 6 months compared to pre-activation baseline:
• NYHA Class
• NT-pro-BNP, as routinely collected as standard of care
• Other biomarkers of end organ damage routinely collected as standard of care (e.g., eGFR, Troponin T, etc.)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/09/14
  •   70
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

g inclusion criteria:
1. Implanted with the Barostim Neo system in accordance with CE-Mark approved criteria for resistant hypertension, within 14 days prior to enrollment.
2. No ongoing adverse events related to the Barostim Neo implant procedure.
3. Barostim Therapy not yet chronically activated.
4. Pre-implant echocardiogram with left ventricular ejection fraction ≥ 50% within 1 month prior to enrollment.
5. On stable, maximally-tolerated, guideline-directed hypertension/heart failure medications for at least 30 days prior to enrollment.
6. Objective evidence of heart failure according to the following criteria:
• Hospitalization for heart failure within 12 months prior to enrollment OR
• Echocardiographic evidence of diastolic dysfunction (LA Volume Index >34 ml/m2 OR E/e >13) within 1 month prior to enrollment OR
• NTproBNP > 220 pg/mL or BNP > 80 pg/mL (in atrial fibrillation, NTproBNP > 600 pg/mL or BNP > 200 pg/mL) within 1 month prior to enrollment
7. Signed a CVRx-approved informed consent form for the registry.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1. Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction.
2. Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • CVRx Incorporated
    • 9201 West Broadway Avenue, Suite 650
    • MN 55445  Minneapolis
    • United States
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • CVRx Incorporated
    • Ms.  Liz  Galle 
    • 9201 West Broadway Avenue, Suite 650
    • MN 55445  Minneapolis
    • United States
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   001 763.416.2331
    •   001 763.416.8400
    •   lgalle at cvrx.com
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • CVRx Incorporated
    • Ms.  Liz  Galle 
    • 9201 West Broadway Avenue, Suite 650
    • MN 55445  Minneapolis
    • United States
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   0017634162331
    •   0017634168400
    •   lgalle at cvrx.com
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • CVRx Incorporated
    • 9201 West Broadway Avenue, Suite 650
    • MN 55445  Minneapolis
    • United States
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.