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Implantable Device

BATwire Implant Kit for Heart Failure

N/A
Recruiting
Research Sponsored by CVRx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The artery planned for the Barostim implant must have no ulcerative carotid arterial plaques
The artery planned for the Barostim implant must have had no prior surgery, radiation, or endovascular stent placement in the carotid artery or the carotid sinus region
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post implant
Awards & highlights

Study Summary

This trial is investigating whether the Barostim System, delivered by the BATwire Implant Kit, is safe and effective in subjects with heart failure. Subjects who are enrolled in the trial meet certain criteria set by the FDA, including having symptoms that remain despite treatment with guideline-directed medical therapy, and having a left ventricular ejection fraction of 35% or less. The trial excludes patients who are indicated for Cardiac Resynchronization Therapy according to AHA/ACC/ESC guidelines.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical surgical risks such as infection at the incision site, bleeding complications from the procedure itself or due to stopping antiplatelet drugs pre-surgery; there could also be device-specific issues like irritation or allergic reaction to materials (silicone/titanium) used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The artery for my Barostim implant does not have ulcerative plaques.
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The artery for my Barostim implant has had no previous surgery, radiation, or stents.
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I am between 21 and 80 years old.
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My BMI is 40 or less, measured within the last 45 days.
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The artery for my Barostim implant is below my jawbone.
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I can stop taking blood thinners like aspirin before getting a Barostim implant.
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The artery for my Barostim implant does not have significant narrowing due to plaque.
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My medical history and condition are suitable for the Barostim System implant.
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I am using birth control and had a negative pregnancy test before my Barostim implant.
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My body's structure allows for safe implant surgery without any obstructions.
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I am considered suitable for surgery based on my ultrasound or CT scan results and medical history.
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I can walk between 150 and 400 meters in six minutes.
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My kidney function, measured by eGFR, is adequate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from Serious Adverse Events (SAEs) related to the implantation of the lead using the BATwire Implant Kit through 30 days post implant
Six Minute Hall Walk (6MHW)

Trial Design

1Treatment groups
Experimental Treatment
Group I: BATwire KitExperimental Treatment1 Intervention
Subjects will be implanted using the BATwire Implant Kit

Find a Location

Who is running the clinical trial?

CVRx, Inc.Lead Sponsor
20 Previous Clinical Trials
8,438 Total Patients Enrolled
11 Trials studying Heart Failure
7,159 Patients Enrolled for Heart Failure
Bradley Knight, MDStudy ChairNorthwestern University
1 Previous Clinical Trials
397 Total Patients Enrolled
Michael Zile, MDStudy ChairMedical University of South Carolina
4 Previous Clinical Trials
1,357 Total Patients Enrolled
4 Trials studying Heart Failure
1,357 Patients Enrolled for Heart Failure

Media Library

BATwire Implant Kit (Implantable Device) Clinical Trial Eligibility Overview. Trial Name: NCT04600791 — N/A
Heart Failure Research Study Groups: BATwire Kit
Heart Failure Clinical Trial 2023: BATwire Implant Kit Highlights & Side Effects. Trial Name: NCT04600791 — N/A
BATwire Implant Kit (Implantable Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04600791 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the cut-off age for this clinical trial different than 85 years old?

"To be eligible for this trial, participants must have an age between 21 and 80. However, there are 22 trials available to those below 18 years old, as well as 691 studies suitable for persons over 65."

Answered by AI

What are the criteria for enrolling in this test?

"This medical trial seeks to recruit 400 heart failure sufferers between the ages 21 and 80 with specific anatomical prerequisites. These requirements include a carotid bifurcation below the mandible, no ulcerative plaques in the carotid artery, being able to discontinue antiplatelet drugs like aspirin (if necessary), achieving an approximate six-minute hall walk of 150 - 400 meters within 45 days prior to implantation (or 60 if monitored by a proctor) as well as having no obstructive vascular structures or neck anomalies that would impede implantation."

Answered by AI

To what extent has enrollment for this research project been capped?

"Affirmative. The information on clinicaltrials.gov shows this research is actively recruiting participants, having been initially published on January 29th 2021 and last updated August 15th 2022. 400 patients are needed to be signed up from 8 distinct medical facilities."

Answered by AI

Are there still opportunities to partake in this clinical research project?

"Affirmative. The information provided on clinicaltrials.gov suggests this medical trial is in the process of recruiting participants, with an initial posting date of January 29th 2021 and a recent update on August 15th 2022. This research requires 400 patients spread across 8 different sites to participate."

Answered by AI

In which areas is this study being conducted?

"This clinical trial has 8 participating sites located throughout the United States. These include St. Louis Heart and Vascular, P.C., Cone Health in Greensboro, Wake Forest in Winston-Salem, and 5 other medical centres."

Answered by AI
~29 spots leftby Jul 2024