NCT04600791

BATwire Implant Kit

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The BATwire Implant Kit Study is a prospective study of up to 400 subjects enrolled at up to 35 U.S. sites. Up to 100 subjects will be implanted with the Barostim System using the BATwire Kit after all screening is complete and all enrollment criteria are met. The study will evaluate the implant experience, safety and effectiveness of the BATwire kit. All subjects will be implanted, and the device will be activated prior to being discharged. Follow-up visits will occur at 0.5, 1, 2, 3, 6 and 12 months post implant. Once the 12-month visit has been completed, the subject is withdrawn from the study and followed in a commercial setting.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	BATwire Implant Kit	The BATwire Implant Kit is a delivery system for the placement of the Barostim Carotid Sinus Lead.

Timeline

• Start date: 2021-01-29
• Primary completion: 2024-08-28
• Completion: 2025-02-17
• First posted: 2020-10-23
• Last updated: 2025-03-30

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study