preCARDIA System for Heart Failure

(VENUS-HF Trial)

Recruiting at 16 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

100 Participants Needed

Trial Summary

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 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. ^{1 2 3 4 5}

What safety data exists for the preCARDIA System for heart failure?

The provided research does not contain specific safety data for the preCARDIA System for heart failure. It discusses general aspects of heart failure treatment, clinical trial design, and monitoring technologies, but does not mention the preCARDIA System or its safety data. ^{6 7 8 9 10}

Is the preCARDIA System a promising treatment for heart failure?

The preCARDIA System is a promising treatment for heart failure because it aims to improve heart function by addressing issues with blood flow and heart pressure. This system could help reduce hospital visits and improve the quality of life for patients with heart failure. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The new heart failure guidelines: strategies for implementation. [2007]

2. England pubmed.ncbi.nlm.nih.gov

Designing meaningful outcome parameters using mobile technology: a new mobile application for telemonitoring of patients with heart failure. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in heart failure: existing measures and future uses. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Use of patient-reported outcomes in heart failure: from clinical trials to routine practice. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Predictors of a sustained response to exercise training in patients with chronic heart failure: a telemonitoring study. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Predischarge initiation of carvedilol in patients hospitalized for decompensated heart failure. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Inpatient initiation of beta-blockade plus nurse management in vulnerable heart failure patients: a randomized study. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Update on device technologies for monitoring heart failure. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures and patient engagement in heart failure clinical trials: multi-stakeholder perspectives. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Rationale and design of the randomized multicentre His Optimized Pacing Evaluated for Heart Failure (HOPE-HF) trial. [2022]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Current Pharmacological Therapies in Heart Failure Patients. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic treatment of congestive heart failure. [2019]

14. England pubmed.ncbi.nlm.nih.gov

His Bundle Pacing: A New Frontier in the Treatment of Heart Failure. [2021]

15. Israel pubmed.ncbi.nlm.nih.gov

Management of congestive heart failure: neuroendocrine approach. [2007]