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BATwire Implant Kit for Heart Failure
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- The artery for my Barostim implant does not have ulcerative plaques.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.I have irregular, slow heartbeats that cause symptoms.The artery for my Barostim implant has had no previous surgery, radiation, or stents.I am between 21 and 80 years old.I have not had a stroke or mini-stroke in the last 3 months.The artery where the Barostim implant will be placed should not have severe narrowing due to plaque buildup.I have a serious heart valve problem.I am currently receiving or will receive IV therapy to strengthen my heart's contractions.My BMI is 40 or less, measured within the last 45 days.The artery for my Barostim implant is below my jawbone.I can stop taking blood thinners like aspirin before getting a Barostim implant.You are allergic to silicone or titanium.I have issues with my cranial nerves as found by an ENT exam.I currently have cancer.You are expected to live for less than a year.The artery for my Barostim implant does not have significant narrowing due to plaque.I have high blood pressure in the lungs.You have a known condition that makes your blood clot too easily and it has not been treated.I have severe lung problems.My heart failure is due to a cause that can be treated or reversed.I have not had heart surgery in the last 3 months.My medical history and condition are suitable for the Barostim System implant.I am using birth control and had a negative pregnancy test before my Barostim implant.I have not had a heart attack in the last 3 months.I have had or am getting a special heart therapy within the last 6 months.I have had, or will have surgery within 45 days of getting a Barostim device.I have had serious bleeding issues in the last 6 months.I have not experienced sudden cardiac death within the last 3 months.I haven't had unstable chest pain in the last 3 months.My body's structure allows for safe implant surgery without any obstructions.I am considered suitable for surgery based on my ultrasound or CT scan results and medical history.I am undergoing or have undergone LVAD therapy or chronic dialysis.I do not have irregular heartbeats that are unpredictable.I have had an organ transplant or am being evaluated for one.I can walk between 150 and 400 meters in six minutes.My kidney function, measured by eGFR, is adequate.
- Group 1: BATwire Kit
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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