BAROSTIM NEO System in the Treatment of Heart Failure

• Status: Unknown status
• Trial end date: 2021-08-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CVRx, Inc.

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.