BAROSTIM NEO System in the Treatment of Heart Failure

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01471860
• Date of registration: 09/11/2011
• Prospective Registration: No
• Primary sponsor: CVRx, Inc.
• Public title: BAROSTIM NEO System in the Treatment of Heart Failure
• Scientific title: Neo Randomized Heart Failure Study
• Date of first enrolment: August 2011
• Target sample size: 94
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01471860
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Canada, France, Germany, Italy, Netherlands

Contacts

• Name: Uta Hoppe, MD
• Affiliation: University of Cologne

Key inclusion & exclusion criteria

Inclusion Criteria:

- Actively participating in the Neo Randomized Heart Failure Study.

- Have signed a revised approved informed consent form for continued participation in
this study.

Exclusion Criteria:

- Treating physician decision that the subject should not continue with therapy.



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Device: BAROSTIM NEO System

Drug: Medical Management

Primary Outcome(s)

To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System [Time Frame: For the duration of the study, up to 5 years.]

Secondary ID(s)

360029

Source(s) of Monetary Support

Please refer to primary and secondary sponsors