Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
NAUNKNOWN
Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance.
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.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT06174623
Intervention or treatment
DEVICE: ModulHeart Support
Conditions
- Heart Failure
- Acute Decompensated Heart Failure
- Cardiorenal Syndrome
- Heart Failure, Congestive
- Heart Failure With Preserved Ejection Fraction
- Heart Failure With Reduced Ejection Fraction
- Diuretic Resistance
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
The Victorian Heart Hospital
Select from list below to view details:
The Victorian Heart Hospital
Clayton, Victoria, Australia
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Who is running the clinical trial?
PMDI
Puzzle Medical Devices Inc.
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
| Device: ModulHeart Support |
What is the study measuring?
Primary Outcome
| Measure | Description | 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
| Measure | Description | 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) |
Are you running this trial?If you're a clinic or sponsor, you can claim this study.
References
Clinical Trials Gov: Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic ResistanceOther trials to consider
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