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Clinical Trial

BATwire Implant Kit Study

NCT: NCT04600791 · TERMINATED

NCT IDNCT04600791
StatusTERMINATED
Start Date2021-01-29
Completion2025-02-17
SponsorCVRx, Inc. (INDUSTRY)
First posted
Last updated

Brief Summary

The purpose of this clinical investigation is to develop valid scientific evidence for the safety and effectiveness of the Barostim System delivered by the BATwire Implant Kit (BATwire Kit) in subjects with heart failure. Subjects may be enrolled if they meet the FDA approved PMA indication for use for the Barostim NEO or Barostim NEO2 device: Subjects who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP \< 1600 pg/ml and excludes patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

Frequently Asked Questions

What is BATwire Implant Kit Study?

BATwire Implant Kit Study is a clinical trial registered under NCT04600791. Current status: TERMINATED.

What is the status of NCT04600791?

The current status of NCT04600791 (BATwire Implant Kit Study) is: TERMINATED.

When did BATwire Implant Kit Study start?

BATwire Implant Kit Study started on 2021-01-29.

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Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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