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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
Must not have
Active myocardial ischemia or acute coronary syndrome (ACS)
Severe peripheral vascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post-discharge
Awards & highlights
No Placebo-Only Group

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.
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).
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.

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.
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I have trouble passing urine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active heart condition related to poor blood flow or a recent heart attack.
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I have severe issues with blood flow in my limbs.
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I have severe heart valve issues.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Freedom from Major Adverse Events through 90 days post-discharge.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ADHF PatientsExperimental Treatment1 Intervention
Treatment with preCARDIA System

Find a Location

Who is running the clinical trial?

preCARDIA IncLead Sponsor
Abiomed Inc.Lead Sponsor
44 Previous Clinical Trials
33,508 Total Patients Enrolled
9 Trials studying Heart Failure
1,971 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
~16 spots leftby Dec 2025
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