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Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance

NOT_YET_RECRUITING

Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance.

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Study details:

The study is a prospective, single-arm, non-randomized feasibility study to evaluate the safety and performance of the ModulHeart System in patients hospitalized with ADHF and diuretic resistance. The ModulHeart system consists of the ModulHeart Delivery System, the ModulHeart Pumps, the ModulHeart Controller, and the ModulHeart Retrieval System.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Admitted to the hospital with a primary diagnosis of ADHF

Clinical signs and/or symptoms of congestion defined as at least one of the following: dyspnea at rest or with minimal exertion, orthopnea, lower extremity edema (≥2+), elevated jugular venous pressure, pulmonary rales, pulmonary vascular congestion on chest x-ray, pleural effusion or ascites

Projected need by the treating clinician for continued treatment with IV diuretic agents for more than 48 hours with the goal of significant fluid removal (more than 1L net fluid loss/24h)

Appropriate intravenous loop diuretic therapy at the time of enrollment, defined as at least the higher of: Furosemide 40mg IV bid or equivalent, IV furosemide or equivalent IV loop diuretic equivalent to ≥2x the total oral daily loop diuretic dose at home in 2 divided doses

Diuretic resistance defined as at least ONE of the following: Urine output of less than 1.5L over 12h following the last diuretic dose, OR Net fluid loss of less than 1L over the last 24 hours, OR Spot urinary sodium concentration of less than 70 mmol/L 2h following the last diuretic dose or cumulative 6-hour natriuresis of less than 100 mmol following the last diuretic dose, OR Clinically unsatisfactory resolution of congestion

Age ≥ 21 years old

Signed informed consent

Exclusion criteria

ADHF related to acute secondary disease (i.e., infection or acute coronary syndrome)

Treatment with high dose inotropes (milrinone ≥0.375 mcg/kg/min, dobutamine ≥5mcg/kg/min or dopamine ≥5mcg/kg/min) and/or treatment with vasopressors to maintain a systolic arterial blood pressure ≥90 mmHg or mean arterial blood pressure ≥60 mmHg

Current or previous support with a durable left ventricular assist device (LVAD) at any time or use of an extracorporeal membrane oxygenation (ECMO), percutaneous ventricular assist devices, intra-aortic balloon pump or patient on home inotropes currently or within the last 30 days

Recent myocardial infarction, percutaneous coronary intervention or surgical revascularization (within the last 30 days) or awaiting planned coronary intervention or surgery

Fixed pulmonary vascular resistance of more than 5 Wood units, estimated PASP of more than 80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure

Prior heart transplant, heart failure due to rejection of a previous heart transplant, or planned heart transplantation

Reanimated cardiac arrest in the last 30 days

Suspected or known amyloid disease or other restrictive cardiomyopathy

Severe bleeding risk precluding anticoagulation: Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 3 days, Gastrointestinal (GI) bleeding within 1 month requiring hospitalization and/or transfusion, Recent major surgery within 1 month if the surgical wound is judged to be associated with an increased risk of bleeding, Platelet count of less than 50,000 cells/mm3, Uncorrectable bleeding diathesis or coagulopathy

Contraindicated anatomy: Descending aortic anatomy that would prevent safe placement of the device (less than 18 mm or more than 28mm thoracoabdominal aorta diameter at deployment location), Abnormalities of the aorta or subclavian or axillary arteries that would prevent safe device placement, including aneurysms, significant tortuosity, or calcifications, Axillary artery anatomy that would preclude safe placement of a 10F sheath including severe obstructive calcification or severe tortuosity, Iliofemoral artery anatomy that would preclude safe placement of a 16F introducer sheath including severe obstructive calcification or severe tortuosity, Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury, Prior endovascular surgery or percutaneous intervention involving the thoracoabdominal aorta or a subclavian/axillary artery or history of aortic dissection

Severe aortic stenosis

Known or suspected contrast induced nephropathy

Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication

Absolute contraindications or allergy to unfractionated heparin (e.g., heparin-induced thrombocytopenia) or device materials (e.g. nickel, titanium) that cannot be adequately treated with pre-medication

Known hematologic diseases such as leukemia, any coagulopathy or hypercoagulable state, sickle cell anemia or thalassemia

Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: Liver disease (cirrhosis of the liver [Child-Pugh class B or C]) or shock liver, History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC less than 0.7, and FEV1 less than 50% predicted, Prior kidney transplant, isolated single kidney, stage V Chronic Kidney Disease (eGFR ≤15) at admission OR use of dialysis, continuous renal replacement therapy (CRRT) or aquapheresis (ultrafiltration) in last 90 days

Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation

Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 90 days prior to the index procedure

Active infection not controlled with antibiotic therapy

Suspected or known pregnancy. Women of child-bearing age should have a negative pregnancy test.

Body mass index (BMI) over 40 kg/m2

Unable or unwilling to undergo screening, device implant and retrieval procedures, and 30-day follow-up

Currently participating in an investigational drug or another device study that may influence the data collected for this study. Observational studies are not considered an exclusion

Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject ability to give written informed consent and/or to comply with study procedures

Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments

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Eligibility

Age eligible for study : 21 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-08-01

Primary completion: 2024-12-01

Study completion finish: 2024-12-01

Study type

TREATMENT

Phase

Trial ID

NCT06174623

Intervention or treatment

DEVICE: ModulHeart Support

Conditions

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure With Reduced Ejection Fraction
• Acute Decompensated Heart Failure
• Cardiorenal Syndrome
• Heart Failure, Congestive
• Diuretic Resistance

Condition: Heart Failure, Heart Failure With Preserved Ejection Fraction and more
DEVICE: ModulHeart Support
Clayton, Victoria, Australia
Sponsor: Puzzle Medical Devices Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

The Victorian Heart Hospital

Research sites nearby

Select from list below to view details:

The Victorian Heart Hospital
Clayton, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ModulHeart System Not Specified	DEVICE: ModulHeart Support The ModulHeart device will be implanted in the descending abdominal aorta.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE)	Not Specified	Baseline to 30-day Follow-Up
Technical success defined as successful device deployment, ability to deliver the treatment and remove the device	Not Specified	Baseline to 30-day Follow-Up
Assisted decongestion success defined as increase in the average hourly rate of urine output during the first 24 hours of ModulHeart-assisted decongestive therapy compared to the last 24 hours of diuretic therapy prior to pump implant	Not Specified	Baseline to 1 day of ModulHeart-assisted decongestive therapy

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change in urine output	Not Specified	Baseline to end of ModulHeart therapy (up to 3 days)
Change in net fluid loss	Not Specified	Baseline to end of ModulHeart therapy (up to 3 days)
Change in natriuresis	Not Specified	Baseline to end of ModulHeart therapy (up to 3 days)
Change in creatinine clearance	Not Specified	Baseline to end of ModulHeart therapy (up to 3 days)
Change in N-terminal pro-B type natriuretic peptide (NT-pro BNP)	Not Specified	Baseline to end of ModulHeart therapy (up to 3 days)
Change in body weight	Not Specified	Baseline to end of ModulHeart therapy (up to 3 days)
Change in thermodilution cardiac output	Not Specified	Baseline to end of ModulHeart therapy (up to 3 days)
Change in right atrial pressure	Not Specified	Baseline to end of ModulHeart therapy (up to 3 days)
Change in mean pulmonary artery pressure	Not Specified	Baseline to end of ModulHeart therapy (up to 3 days)

Frequently Asked Questions

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References

Clinical Trials Gov: Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance