Baroreflex Activation Therapy in Heart Failure
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Nov 2011
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 29, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
August 26, 2021
CompletedAugust 26, 2021
August 1, 2021
1.7 years
November 29, 2011
July 12, 2021
August 3, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min)
Change in muscle sympathetic nerve activity (MSNA) in bursts/min at 6 months compared to baseline
6 months
Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats)
Changes in Muscle Sympathetic Nerve Activity (bursts/100 heartbeats) at 6 months compared to baseline
6 months
Secondary Outcomes (7)
Change in Systolic Blood Pressure
6 months
Change in Diastolic Blood Pressure
6 months
Change in Heart Rate
6 months
Change in Six-Minute Hall Walk
6 months
New York Heart Association (NYHA) Class
Six months
- +2 more secondary outcomes
Study Arms (1)
Device group
EXPERIMENTALBarostim Neo system
Interventions
Baroreflex Activation Therapy using the Barostim Neo System
Eligibility Criteria
You may qualify if:
- Age at least 21 years
- Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CVRx, Inc.lead
Study Sites (1)
MultiMedica
Milan, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Global Clinical Research
- Organization
- CVRx
Study Officials
- PRINCIPAL INVESTIGATOR
Edoardo G Gronda, MD, FESC
MultiMedica
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2011
First Posted
December 2, 2011
Study Start
November 1, 2011
Primary Completion
July 1, 2013
Study Completion
March 1, 2015
Last Updated
August 26, 2021
Results First Posted
August 26, 2021
Record last verified: 2021-08