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Device

preCARDIA System for Heart Failure (VENUS-HF Trial)

N/A

Recruiting

Research Sponsored by preCARDIA Inc

Eligibility Criteria Checklist

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

Must have

Stage C-D systolic heart failure

NYHA Class III-IV heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days post-discharge

Awards & highlights

VENUS-HF Trial Summary

This trial is testing a new system to help people with ADHF. The goal is to see if it is safe and if it works well.

Who is the study for?

This trial is for individuals with advanced heart failure (NYHA Class III-IV), specifically those who aren't responding well to diuretics and have Stage C-D systolic heart failure. It's not suitable for patients with recent heart attacks, severe valve insufficiency in the heart, or serious blood vessel problems.Check my eligibility

What is being tested?

The trial is evaluating the safety and effectiveness of a device called the preCARDIA System designed to help manage symptoms in patients suffering from acute decompensated heart failure (ADHF).See study design

What are the potential side effects?

While specific side effects are not listed, interventions like the preCARDIA System may cause discomfort at the site of insertion, potential vascular complications, or irregular heartbeat during use.

VENUS-HF Trial Eligibility Criteria

Inclusion Criteria

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

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My heart's pumping ability is significantly reduced.

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I have severe heart failure.

Select...

I have trouble passing urine.

VENUS-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days post-discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days post-discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post-discharge 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 Major Adverse Events through 90 days post-discharge.

VENUS-HF Trial Design

1Treatment groups

Experimental Treatment

Group I: ADHF PatientsExperimental Treatment1 Intervention

Treatment with preCARDIA System

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

preCARDIA IncLead Sponsor

Abiomed Inc.Lead Sponsor

41 Previous Clinical Trials

34,455 Total Patients Enrolled

8 Trials studying Heart Failure

1,906 Patients Enrolled for Heart Failure

Media Library

preCARDIA system (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03836079 — N/A

Heart Failure Research Study Groups: ADHF Patients

Heart Failure Clinical Trial 2023: preCARDIA system Highlights & Side Effects. Trial Name: NCT03836079 — N/A

preCARDIA system (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03836079 — N/A

Frequently Asked Questions

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

Are there multiple locations where this experiment is taking place?

"The current clinical trial is taking place in 5 different locations, including Houston, Portland and Boston. To minimise travel needs, potential participants should select the closest clinic to them when enrolling."

Answered by AI

Are participants currently being invited to join this experiment?

"That is accurate. According to clinicaltrials.gov, this trial posted on July 31st 2019 and was recently adjusted on August 17th 2022; the study aims to enroll 60 individuals at 5 distinct sites."

Answered by AI

Does this clinical investigation accept participants aged 60 or above?

"According to the standard qualifications, participants between 18 and 85 years old are eligible for this trial. Notably, there are 100 trials available specifically designed for those below 18 while 918 studies have been allocated to seniors over 65."

Answered by AI

What is the upper limit of participants in this experiment?

"To execute this clinical trial, 60 participants who meet the pre-defined criteria must be recruited. The sponsor organization, preCARDIA Inc., will run the study out of a number of locations including Houston Methodist in Houston and Providence Health & Services in Portland."

Answered by AI

Who would best benefit from participating in this clinical study?

"This medical trial requires patients to have a cardiovascular condition and be within the age range of 18-85. Approximately 60 individuals are expected to take part in this study."

Answered by AI

Recent research and studies

Circulation: Heart FailureJournal

Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients with Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study

Kapur, Navin K., Michael S. Kiernan, Irakli Gorgoshvili, Rayan Yousefzai, Esther E. Vorovich, Ryan J. Tedford, Andrew J. Sauer, et al.. 2022. “Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients with Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study”. Circulation: Heart Failure. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circheartfailure.121.008934.

Circulation: Heart FailureJournal

Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients with Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study

clinicaltrials.govStudy

SVC Occlusion in Subjects With Acute Decompensated Heart Failure

2019. "SVC Occlusion in Subjects With Acute Decompensated Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03836079.

All > Congestive Heart Failure