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Autonomic Regulation Therapy

VITARIA System for Heart Failure

Q: Has recruitment begun for this examination?

Confirmed. According to the info on clinicaltrials.gov, this research project is actively recruiting patients; it was first publicized on May 1st 2018 and has been edited as recently as May 31 2022. 800 individuals are being sought across 26 medical centres for participation in this trial.

Q: Are there any trials of this nature being conducted in North America at present?

The University of <a href="https://www.withpower.com/clinical-trials/mississippi">Mississippi</a> Medical Center, MetroHealth System in Cleveland and the Greater Los Angeles VA Medical Centre are three sites participating in this trial. Other locales across the US have also been selected as enrolment points for patient recruitment.

Q: What is the current count of individuals taking part in this research?

The study sponsor, LivaNova, is recruiting 800 participants to meet the clinical trial's inclusion criteria. To facilitate this objective, they are operating out of University of <a href="https://www.withpower.com/clinical-trials/mississippi">Mississippi</a> Medical Center in Jackson and MetroHealth System in Cleveland.

N/A

Waitlist Available

Research Sponsored by LivaNova

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Left ventricular ejection fraction (EF) ≤ 35% and left ventricular end-diastolic diameter (LVEDD) < 8.0 cm, as confirmed by the core echocardiography laboratory during screening

N-terminal pro-BNP (NT-proBNP) level of at least 800 pg/mL, as determined by the core laboratory; or NT-proBNP level of at least 1200 pg/mL, as determined by the core laboratory, for patients with permanent atrial fibrillation or reporting signs or symptoms of atrial fibrillation at the time that the NT-proBNP sample is drawn

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

Study Summary

This trial is testing a new therapy for heart failure patients.

Eligible Conditions

Heart Failure
Congestive Heart Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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for the study, were used to identify patients with heart failure The text is saying that the left ventricular ejection fraction (EF) and left ventricular end-diastolic diameter (LVEDD) were used to identify patients with heart failure.

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An NT-proBNP level of at least 800 pg/mL, as determined by the core laboratory, is required for patients with permanent atrial fibrillation or reporting signs or symptoms of atrial fibrillation at the time that the NT-proBNP sample is drawn.

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A patient was given a standard cardiac assessment, which included a history, physical exam, and electrocardiogram

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I am willing and capable of providing informed consent.

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This person is able to participate in all the tests that are related to this clinical investigation.

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You have moderate to severe heart failure symptoms and have been hospitalized for heart failure in the past 12 months.

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This is not an exclusion criterion, rather it is a question to gather demographic information about the participant.

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This is not an exclusion criterion. It is simply a question about the participant's weight.

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You are 18 years old or older.

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You are physically able and willing to walk for 6 minutes multiple times during the study, and you can walk between 150 and 450 meters at the start. If you have any symptoms that limit your ability to walk, they should be caused mainly by heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cardiovascular mortality and HF hospitalization

Event-free rate

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TherapyExperimental Treatment1 Intervention

VITARIA system implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy

Group II: ControlActive Control1 Intervention

Stable guideline-directed medical therapy

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

LivaNovaLead Sponsor

64 Previous Clinical Trials

32,112 Total Patients Enrolled

16 Trials studying Heart Failure

4,867 Patients Enrolled for Heart Failure

Frequently Asked Questions

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

Has recruitment begun for this examination?

"Confirmed. According to the info on clinicaltrials.gov, this research project is actively recruiting patients; it was first publicized on May 1st 2018 and has been edited as recently as May 31 2022. 800 individuals are being sought across 26 medical centres for participation in this trial."

Answered by AI

Are there any trials of this nature being conducted in North America at present?

"The University of Mississippi Medical Center, MetroHealth System in Cleveland and the Greater Los Angeles VA Medical Centre are three sites participating in this trial. Other locales across the US have also been selected as enrolment points for patient recruitment."

Answered by AI

What is the current count of individuals taking part in this research?

"The study sponsor, LivaNova, is recruiting 800 participants to meet the clinical trial's inclusion criteria. To facilitate this objective, they are operating out of University of Mississippi Medical Center in Jackson and MetroHealth System in Cleveland."

Answered by AI