preCARDIA System for Heart Failure
(VENUS-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Safety and performance evaluation of the preCARDIA System for patients with ADHF.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications.
What safety data exists for the preCARDIA System for heart failure?
Is the preCARDIA System a promising treatment for heart failure?
What data supports the idea that preCARDIA System for Heart Failure is an effective treatment?
The available research does not provide specific data on the effectiveness of the preCARDIA System for Heart Failure. Instead, it discusses the importance of using patient-reported outcomes and systematic processes to improve heart failure treatment. Without direct evidence from the research, we cannot conclude the effectiveness of the preCARDIA System compared to other treatments.1112131415
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with the preCARDIA System for SVC occlusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- preCARDIA system
preCARDIA system is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
preCARDIA Inc
Lead Sponsor
Abiomed Inc.
Lead Sponsor