preCARDIA System for Heart Failure

(VENUS-HF Trial)

No longer recruiting at 17 trial locations

Overseen By Kelsey Hedquist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: preCARDIA Inc

Disqualifiers: Myocardial ischemia, ACS, valve insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the preCARDIA system, a medical device, to determine its safety and effectiveness for people with heart failure. It specifically targets patients with advanced heart failure who do not respond well to current medication, particularly those experiencing fluid buildup and difficulty breathing. Suitable candidates for this trial include individuals with severe heart failure symptoms that affect daily life, such as frequent shortness of breath, despite taking prescribed medications. As an unphased trial, this study provides patients with access to innovative treatment options that may enhance their quality of life.

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 prior data suggests that the preCARDIA System is safe for patients with ADHF?

Research has shown that the preCARDIA system has been tested for safety in people with acute decompensated heart failure (ADHF). In these studies, the device manages fluid build-up by temporarily blocking a large vein that carries blood to the heart, aiming to reduce congestion.

The results indicate that the preCARDIA system is generally safe for patients, with no major safety concerns reported. Acting like a "mechanical diuretic," the system helps remove excess fluid from the body, similar to some medications but using a device instead. Patients have tolerated this approach well, with no serious side effects directly linked to the device.

Overall, the preCARDIA system appears to be a promising and safe option for managing heart failure symptoms. However, as with any medical treatment, potential participants should consult their healthcare provider to understand what joining a clinical trial would mean for them personally. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the preCARDIA system because it offers a novel approach to managing heart failure, specifically acute decompensated heart failure (ADHF). Unlike traditional treatments, which often include medications like diuretics and vasodilators, the preCARDIA system is a minimally invasive device designed to regulate fluid levels and reduce the workload on the heart. It does this by using a balloon catheter to intermittently occlude the superior vena cava, which helps optimize fluid management and improve heart function. This innovative mechanism has the potential to provide quicker, more effective relief of symptoms compared to conventional therapies.

What evidence suggests that the preCARDIA System is effective for heart failure?

Research has shown that the preCARDIA System, which participants in this trial will receive, might help patients with acute decompensated heart failure (ADHF). Studies have found it promising as a safe way to ease heart strain by mechanically removing extra fluid. This process helps manage symptoms by reducing the heart's workload, which is crucial for ADHF patients. Early clinical data suggest that this device may offer advantages over current treatments by specifically targeting fluid buildup, a major issue in heart failure. The FDA has specially recognized the preCARDIA System for its innovative approach. ^{4 6 7 8 9}

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

My heart's pumping ability is significantly reduced.

I have severe heart failure.

I have trouble passing urine.

Exclusion Criteria

I have an active heart condition related to poor blood flow or a recent heart attack.

I have severe issues with blood flow in my limbs.

I have severe heart valve issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the preCARDIA System for SVC occlusion

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• preCARDIA system

Trial Overview

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).

How Is the Trial Designed?

Group I: ADHF Patients Experimental Treatment 1 Intervention

Treatment with preCARDIA System

preCARDIA system is already approved in United States for the following indications:

Approved in United States as preCARDIA System for:

• Acute Decompensated Heart Failure (ADHF)

Who Is Running the Clinical Trial?

preCARDIA Inc

Lead Sponsor

Trials

1

Recruited

100+

Abiomed Inc.

Lead Sponsor

Trials

47

Recruited

33,900+

Founded

1981

Headquarters

Danvers, United States

Known For

Heart Recovery Technologies

Top Products

Impella heart pumps, AbioCor, Breethe OXY-1 System

Published Research Related to This Trial

The HOPE-HF trial is investigating the effects of His-bundle pacing on exercise capacity and heart failure symptoms in 160 patients with prolonged PR intervals and left ventricular impairment, aiming to improve their heart function and quality of life.

This study will compare the effects of optimized His-bundle pacing against standard backup pacing over 6 months, with the primary focus on changes in exercise capacity measured by peak oxygen uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the randomized multicentre His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) trial. Keene, D., Arnold, A., Shun-Shin, MJ., et al.[2022]

Initiating beta-blocker treatment in hospitalized heart failure patients with reduced left ventricular ejection fraction (LVEF) and providing structured nurse management significantly increased medication adherence (96% vs. 48%) and improved heart failure symptoms after 6 months.

The intervention group experienced an 84% reduction in rehospitalization rates (3 vs. 19) compared to usual care, highlighting the effectiveness of this approach in a vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient initiation of beta-blockade plus nurse management in vulnerable heart failure patients: a randomized study. Krantz, MJ., Havranek, EP., Haynes, DK., et al.[2018]

ACE inhibitors are the most effective treatment for heart failure, significantly improving survival rates in various patient populations, including those with severe and mild to moderate heart failure.

New therapies like vesnarinone have shown promise in reducing mortality, while beta-blockers with vasodilating properties, such as carvedilol and bucindolol, are gaining renewed interest in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment of congestive heart failure. Carson, P.[2019]

Patient-reported outcomes (PROs) are essential for capturing the real-life impact of heart failure on patients, including their symptoms and quality of life, but are not routinely included in clinical trials.

To improve the relevance of PROs in heart failure research and patient care, there is a need for standardized measures and methods for data collection and analysis, as well as further research to establish clinically important thresholds for these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures and patient engagement in heart failure clinical trials: multi-stakeholder perspectives. Zannad, F., Alikhaani, J., Alikhaani, S., et al.[2023]

Many patients with heart failure are not receiving life-prolonging therapies they are eligible for, highlighting a significant treatment gap in the use of evidence-based medications like ACE inhibitors, beta-blockers, and aldosterone antagonists.

Initiating evidence-based therapies before hospital discharge has been shown to improve the use of these medications, particularly beta-blockers, and systematic processes can enhance the overall prescription rates, ultimately aiming to reduce the high mortality and morbidity associated with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The new heart failure guidelines: strategies for implementation. O'Connor, CM.[2007]

A new cardio patient monitoring platform (CPMP) was tested in a feasibility trial with 10 heart failure patients, showing that daily step counts recorded by smart devices can serve as meaningful patient-reported outcome measures (PROMs).

The study found a significant increase in average daily steps from 3612 to 7069 over two months, which correlated well with traditional measures of cardiac performance, indicating that this platform could effectively monitor patient health post-hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing meaningful outcome parameters using mobile technology: a new mobile application for telemonitoring of patients with heart failure. Werhahn, SM., Dathe, H., Rottmann, T., et al.[2022]

Patient-reported outcomes (PROs) are essential for understanding heart failure (HF) from the patient's perspective, as they capture the impact of the disease on daily life and can improve treatment adherence.

Despite their proven effectiveness in evaluating disease status and correlating with prognosis in clinical trials, the use of PROs in everyday clinical practice for heart failure remains limited, highlighting the need for strategies to integrate patient perspectives into care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of patient-reported outcomes in heart failure: from clinical trials to routine practice. Savarese, G., Lindenfeld, J., Stolfo, D., et al.[2023]

In a study of 30 patients with chronic heart failure, those who adhered to a home-based exercise training program showed sustained improvements in exercise capacity (peak oxygen consumption) after 12 months, while nonadherent patients did not.

Telemonitoring was effective in tracking adherence to exercise, highlighting that ongoing participation is crucial for maintaining quality of life and exercise benefits in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of a sustained response to exercise training in patients with chronic heart failure: a telemonitoring study. Smart, N., Haluska, B., Jeffriess, L., et al.[2016]

His bundle pacing offers a promising alternative to traditional biventricular pacing for heart failure patients, as it activates the ventricles through the natural His-Purkinje system, potentially leading to more effective and physiological pacing.

This technique may not only improve outcomes for patients with left bundle branch block but also expand treatment options for those with PR prolongation and narrow QRS duration, addressing limitations of current pacing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

His Bundle Pacing: A New Frontier in the Treatment of Heart Failure. Ali, N., Keene, D., Arnold, A., et al.[2021]

Heart failure affects over 23 million people globally and is a leading cause of hospitalization, highlighting its significant public health impact and the need for effective management strategies.

Adherence to evidence-based treatments for heart failure has been shown to improve patient outcomes, yet actual usage of these recommended therapies at proper dosages remains lower than expected, indicating a gap in treatment implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Pharmacological Therapies in Heart Failure Patients. Muiesan, ML., Paini, A., Agabiti Rosei, C., et al.[2018]

The Heart Failure Collaboratory developed a streamlined case report form (CRF) for heart failure clinical trials, reducing the number of data items from 176 to 75 baseline items and 6 events, which aims to improve trial efficiency and reduce administrative burdens.

This new consensus CRF, created with input from various stakeholders including patients and the FDA, is designed to enhance data compatibility across trials, ultimately improving the integrity of evidence collected in heart failure device development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development. Psotka, MA., Fiuzat, M., Carson, PE., et al.[2020]

Traditional methods of monitoring heart failure, such as tracking patient-reported symptoms and body weight, have not been effective in reducing hospitalizations due to worsening congestive heart failure (CHF).

Newer monitoring systems, including those using implantable devices and invasive hemodynamic monitoring, show promise in detecting early signs of CHF before symptoms develop, although they are not yet FDA approved and require further clinical validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on device technologies for monitoring heart failure. Singh, B., Russell, SD., Cheng, A.[2021]

Patient-reported outcomes (PROs) are crucial in heart failure management as they provide insights into how patients feel and function, which can enhance patient-centered care.

The review emphasizes the need to advance PRO measurement and integrate these assessments into national databases and electronic health records to improve the quality of care for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in heart failure: existing measures and future uses. Thompson, LE., Bekelman, DB., Allen, LA., et al.[2022]

Heart failure is driven by complex neuroendocrine responses that lead to harmful effects like increased blood pressure and fluid retention, worsening the condition of the heart.

Current therapies focus on reducing the heart's workload through vasodilators and beta blockers, which improve heart function and responsiveness, while inotropic agents are used for patients with severe heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of congestive heart failure: neuroendocrine approach. Shmuely, H., Sclarovsky, S., Rosenfeld, JB.[2007]

The IMPACT-HF study, involving 363 patients with heart failure, found that starting beta-blocker therapy (carvedilol) before hospital discharge significantly increased the likelihood of patients continuing beta-blocker treatment at 60 days (91.2% vs 73.4%).

Initiating beta-blocker therapy before discharge is a safe and effective strategy that may enhance adherence to treatment guidelines for heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predischarge initiation of carvedilol in patients hospitalized for decompensated heart failure. Gattis, WA., O'Connor, CM.[2018]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38147412/

Procedural Insights and Clinical Outcomes of a Novel ...

The preCARDIA device appears to be a safe mechanical diuretic strategy to manage patients with acute decompensated heart failure beyond current therapeutic ...

2.

icrjournal.com

icrjournal.com/articles/novel-superior-vena-cava-occlusion-system-treatment-acute-congestive-heart-failure-pre?language_content_entity=en

A Novel Superior Vena Cava Occlusion System for the ...

... Acute Congestive Heart Failure: Pre-clinical and Clinical Data ... He stated that congestion plays an important role in acute decompensated heart failure (ADHF) ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.119.006731

Conceptual Considerations for Device-Based Therapy in ...

The clinical, societal, and financial burdens of acute decompensated heart failure (ADHF) are well established. ADHF remains the most common ...

4.

crfconnect.com

crfconnect.com/episode/safety-and-efficacy-of-the-precardia-system-to-mechanically-reduce-cardiac-preload-for-acutely-decompensated-heart-failure-the-expanded-venous-heart-failure-venus-hf-early-feasibility-study-4643

Heart Failure

Safety and Efficacy of the preCARDIA System to Mechanically Reduce Cardiac Preload for Acutely Decompensated Heart Failure: The Expanded ...

5.

dicardiology.com

dicardiology.com/content/fda-grants-breakthrough-device-designation-precardia-catheter-based-heart-failure-treatment

FDA Grants Breakthrough Device Designation for ...

... preCardia catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF). The FDA's ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.121.008934

The VENUS-HF Early Feasibility Study

We report the first-in-human experience of intermittent superior vena cava occlusion using the preCARDIA system to reduce congestion in acutely decompensated ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35000420/

The VENUS-HF Early Feasibility Study

We report the first-in-human experience of intermittent superior vena cava occlusion using the preCARDIA system to reduce congestion in acutely decompensated ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03836079

Study Details | NCT03836079 | SVC Occlusion in Subjects ...

The objective of this early feasibility study is to evaluate the safety and performance of the preCARDIA System for Superior Vena Caval (SVC) intermittent ...

9.

abiomed.com

abiomed.com/en-us/about-us/news-and-media/press-releases/early-feasibility-study-demonstrates-successful-use-of-abiomeds-precardia-technology

Early Feasibility Study Demonstrates Successful Use of ...

The preCARDIA system is designed to improve decongestion in acutely decompensated heart failure (ADHF) patients by intermittently occluding the superior vena ...