Doraya Catheter for Heart Failure

Recruiting at 13 trial locations

Overseen By Judit Adorjan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Revamp Medical Inc.

Must not be taking: High dose inotropes

Disqualifiers: Low blood pressure, Recent heart attack, Severe renal dysfunction, Advanced liver disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 24 hours

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the Doraya Catheter, a device that helps manage fluid levels, in heart failure patients who do not respond well to typical treatments. The catheter works by controlling and managing excess fluid in the body.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that participants should not have been treated with high-dose IV inotropes (medications that help the heart pump more effectively) within 2 days prior to enrollment.

What data supports the effectiveness of the Doraya Catheter treatment for heart failure?

The research suggests that device-based therapies, like the Doraya Catheter, offer promise for improving symptoms and prognosis in heart failure patients, as they can address structural heart issues that drugs alone cannot. Similar devices have shown potential in relieving symptoms and improving outcomes in heart failure. ^{1 2 3 4 5}

How is the Doraya Catheter treatment for heart failure different from other treatments?

The Doraya Catheter is unique because it is a specialized device used to manage heart failure by potentially improving blood flow dynamics, unlike traditional drug therapies that primarily focus on altering heart function or fluid balance. ^{6 7 8 9 10}

Research Team

Mike Favet

Principal Investigator

CEO

Eligibility Criteria

This trial is for hospitalized patients with acute decompensated heart failure (ADHF) who aren't responding well to IV diuretics. They must have fluid overload and high levels of certain heart-related biomarkers. It's not for those with very low blood pressure, recent heart attacks or interventions, complex congenital heart disease, severe valve disorders, active infections, or critical damage in multiple body systems.

Inclusion Criteria

I am in the hospital because of acute heart failure.

IV diuretics do not work well for me.

You have signs of having too much fluid in your body.

Exclusion Criteria

Your blood pressure is too low (less than 90 mmHg) when checked at the screening.

I have a severe heart valve problem or need surgery for it.

I have a serious heart condition like myocarditis or cardiomyopathy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Doraya Catheter with diuretics or diuretics only

24 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• Doraya catheter

Trial Overview The DORAYA-HF study is testing the Doraya Catheter's ability to manage fluid overload in ADHF patients who don't respond adequately to standard diuretic therapy. The goal is to assess how feasible and safe this catheter is when used in a real-world clinical setting.

Participant Groups

Group I: Doraya Catheter Experimental Treatment 1 Intervention

Doraya Catheter with diuretics

Group II: Control Arm Active Control 1 Intervention

Diuretics only

Who Is Running the Clinical Trial?

Revamp Medical Inc.

Lead Sponsor

Trials

1

Recruited

30+

Findings from Research

In a study of 11,887 critically ill patients with cardiac disease, early pulmonary artery catheter placement did not improve 28-day mortality compared to those without the catheter, indicating no survival benefit from this intervention.

The use of pulmonary artery catheters was linked to fewer ventilation-free and vasopressor-free days in surgical patients, while nonsurgical patients experienced a higher risk of acute kidney injury, suggesting that the catheter's impact varies based on the patient's surgical status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early pulmonary artery catheterization is not associated with survival benefits in critically ill patients with cardiac disease: An analysis of the MIMIC-IV database. Wu, J., Liang, Q., Hu, H., et al.[2022]

Interventional heart failure therapies, including mechanical assist devices and heart transplantation, are crucial for treating end-stage refractory heart failure when drug therapies are insufficient.

Emerging treatments like cellular or stem cell therapy show promise for heart failure, alongside the importance of palliative care and self-care strategies in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The new concept of ''interventional heart failure therapy'': part 2--inotropes, valvular disease, pumps, and transplantation. Thompson, KA., Philip, KJ., Simsir, S., et al.[2010]

In a study of 56 patients with refractory congestive heart failure treated with chronic vasodilator therapy (hydralazine and nitrates), 73% reported subjective improvement and 59% showed improvement in heart function classifications within the first 6 months, with many sustaining these improvements over time.

Mortality rates were high, but significantly lower in patients who responded to treatment (21% in responders vs. 55% in nonresponders at 1 year), highlighting the importance of clinical response and specific hemodynamic indicators in predicting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term vasodilator therapy for heart failure: clinical response and its relationship to hemodynamic measurements. Massie, B., Ports, T., Chatterjee, K., et al.[2019]

The Heartpod device developed by Savacor allows for real-time measurement of left atrial pressure in patients with congestive heart failure, enabling them to monitor their condition more effectively.

This innovative implantable device empowers patients to adjust their treatment based on precise intra-cardiac pressure data, potentially improving management of their heart failure symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Heartpod implantable heart failure therapy system. Walton, AS., Krum, H.[2022]

Device-based therapies, such as implantable defibrillators, are crucial for improving outcomes in heart failure patients, especially those who have experienced life-threatening arrhythmias like ventricular fibrillation.

Cardiac resynchronization therapy (CRT) shows promise in alleviating heart failure symptoms and is currently being evaluated in large trials (CARE-HF and COMPANION) for its impact on patient morbidity and mortality, highlighting the need for careful patient selection and trial integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome studies with device therapy in patients with heart failure. Cleland, JG., Thackray, S., Goodge, L., et al.[2019]

Invasive monitoring using the Swan-Ganz catheter can significantly improve patient management in cases of acute myocardial infarction by providing critical measurements such as cardiac pressures and output.

This catheter is particularly beneficial for patients experiencing severe left or right heart failure, complicated myocardial infarction, or severe hypovolemia, helping to guide treatment decisions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hemodynamics monitoring: correlations of clinical and invasive methods]. Bloch, A., Scheidegger, D.[2012]

Percutaneous catheter valvuloplasty is an effective treatment for calcified aortic stenosis in elderly patients, achieving a primary success rate of 73% in a study of 37 patients aged 60-88 years.

The procedure can maintain functional improvements for up to 6 months in patients with moderate myocardial dysfunction, but those with severe dysfunction may experience recurrent heart failure and complications, indicating the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of percutaneous catheter valvuloplasty for calcified aortic stenosis in the elderly. Drobinski, G., Lechat, P., Metzger, JP., et al.[2019]

In a study involving three patients with severe pulmonic stenosis, balloon pulmonary valvuloplasty using the Inoue catheter significantly reduced right ventricular systolic pressure from 140 mmHg to 40 mmHg, indicating effective relief of obstruction.

The procedure also decreased the pulmonary valvular peak to peak systolic gradients from 120 mmHg to 8 mmHg, demonstrating that this technique is both feasible and safe for treating severe valvular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary valvuloplasty using Inoue balloon catheter. Bahl, VK., Chandra, S., Wasir, HS.[2019]

A new catheter designed for patients with severe aortic stenosis allows for high-pressure injections and maintains maneuverability, making it effective for catheterization in challenging cases.

In a study of 23 patients, the catheter successfully provided good-quality ventriculograms in 22 cases, demonstrating its efficacy and reliability for routine use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new catheter design for use in patients with critical aortic stenosis. Agarwal, JB., Klein, LW.[2019]

Valvuloplasty using a large-lumen balloon catheter effectively reduced the pressure gradient across the aortic valve in two patients with calcified aortic valve stenosis, leading to significant clinical improvement and resolution of cardiogenic shock symptoms.

The procedure was performed safely in both patients, with no significant increase in aortic insufficiency, suggesting that valvuloplasty can be a viable palliative treatment option for high-risk patients with aortic valve stenosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transfemoral valvuloplasty in calcified aortic valve stenosis]. Bussmann, WD., Reifart, N., Sievert, H., et al.[2006]

References

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

Early pulmonary artery catheterization is not associated with survival benefits in critically ill patients with cardiac disease: An analysis of the MIMIC-IV database. [2022]

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

The new concept of ''interventional heart failure therapy'': part 2--inotropes, valvular disease, pumps, and transplantation. [2010]

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

Long-term vasodilator therapy for heart failure: clinical response and its relationship to hemodynamic measurements. [2019]

4. Australia pubmed.ncbi.nlm.nih.gov

The Heartpod implantable heart failure therapy system. [2022]

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

Outcome studies with device therapy in patients with heart failure. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Hemodynamics monitoring: correlations of clinical and invasive methods]. [2012]

7. England pubmed.ncbi.nlm.nih.gov

Results of percutaneous catheter valvuloplasty for calcified aortic stenosis in the elderly. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Pulmonary valvuloplasty using Inoue balloon catheter. [2019]

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

A new catheter design for use in patients with critical aortic stenosis. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Transfemoral valvuloplasty in calcified aortic valve stenosis]. [2006]