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Baroreflex Activation Therapy in Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT01484288
First received: November 29, 2011
Last updated: April 11, 2014
Last verified: April 2014

November 29, 2011
April 11, 2014
November 2011
May 2014   (final data collection date for primary outcome measure)
Changes in sympathetic nervous system activity at 6 months from baseline [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01484288 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Baroreflex Activation Therapy in Heart Failure
Baroreflex Activation Therapy in Heart Failure

The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Device: Barostim Neo System
Baroreflex Activation Therapy using the Barostim Neo System
Other Names:
  • XR-1 System
  • Neo system
Experimental: Device group
Barostim Neo system
Intervention: Device: Barostim Neo System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
November 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age at least 21 years
  • Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks

Exclusion Criteria:

  • Significant carotid plaque or stenosis
  • Known or suspected baroreflex failure or autonomic neuropathy
  • Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months
  • Heart failure secondary to a reversible condition
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01484288
360025
Yes
CVRx, Inc.
CVRx, Inc.
Not Provided
Principal Investigator: Edoardo G Gronda, MD, FESC MultiMedica
CVRx, Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP