BATwire Implant Kit for Heart Failure

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: CVRx, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a device called the Barostim System, implanted using the BATwire Kit, in heart failure patients who don't respond to standard treatments. The device sends electrical signals to help the heart work better and reduce symptoms. Baroreflex activation therapy (BAT) has been studied for its safety and efficacy in heart failure patients, often in combination with other devices like ICDs.

Eligibility Criteria

Adults aged 21-80 with heart failure, who are symptomatic despite treatment, have an ejection fraction ≤35%, NT-proBNP <1600 pg/ml, and aren't candidates for Cardiac Resynchronization Therapy. They must be suitable for surgery based on medical history and tests like CDU or CTA, have specific artery conditions for the implant, can stop certain drugs if needed before the procedure, use birth control if applicable, meet Barostim's usage criteria after screening and baseline assessments.

Inclusion Criteria

The artery for my Barostim implant does not have ulcerative plaques.

The artery for my Barostim implant has had no previous surgery, radiation, or stents.

At the end of screening and baseline, the subject still meets the Barostim Indication for Use

+14 more

Exclusion Criteria

I cannot or do not want to follow the study's medication and check-up schedule.

I had a heart procedure like stenting or bypass surgery within the last 3 months.

I have a condition affecting my body's ability to control blood pressure or nerve function.

+24 more

Participant Groups

The BATwire Implant Kit is being tested to see if it's safe and effective in patients with heart failure. The trial involves surgically implanting the Barostim System using this kit to help manage symptoms of heart failure in those who haven't improved sufficiently with standard treatments.

1Treatment groups

Experimental Treatment

Group I: BATwire KitExperimental Treatment1 Intervention

Subjects will be implanted using the BATwire Implant Kit