Heart Failure study: Aortix System
Official title Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
ClinicalTrials.gov ID: NCT05677100
What this study is testing
- What it's testing
- The study aims to see if the Aortix device can help patients with acute heart failure who still have fluid buildup after usual medical care.
- Who it's for
- Adults hospitalized for acute heart failure who are not getting better with diuretic medication, regardless of heart pumping strength.
- What's involved
- Participants will be randomly assigned to receive either the Aortix device or continue their usual medical treatment. They will have regular check‑ups and tests to monitor their heart and fluid levels.
- Time commitment
- The study lasts until the patient’s heart failure is stabilized, with follow‑up visits scheduled as needed during that time.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF);
- Patients should be on maximally tolerated diuretic therapy and not diuresing sufficiently before being enrolled in DRAIN-HF.
- Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water or ascites...
- Age \>21 years and able to provide written informed consent;
- Negative pregnancy test if patient is of child-bearing potential.
You likely can't join if
- Treatment with high dose IV inotropes within the last 48 hours prior to enrollment.
- Active and ongoing hypotension with a systolic blood pressure \<90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<60 mmHg...
- Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment;
- An estimated PASP of \>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure;
- Acute kidney failure defined as an increase in serum creatinine to ≥4.0mg/dL (≥353.6 µmol/L) at enrollment;
- Evidence of contrast induced nephropathy, nephritis or nephrotic syndrome;
See the full eligibility criteria
Who can join
- Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF);
- Patients should be on maximally tolerated diuretic therapy and not diuresing sufficiently before being enrolled in DRAIN-HF.
- Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water or ascites after treatment with IV diuretics per inclusion criterion 2.;
- Age \>21 years and able to provide written informed consent;
- Negative pregnancy test if patient is of child-bearing potential.
What rules you out
- Treatment with high dose IV inotropes within the last 48 hours prior to enrollment. High dose is defined as \>5 µg/kg/min dopamine OR \>5 µg/kg/min dobutamine OR \>0.375 µg/kg/min milrinone;
- Active and ongoing hypotension with a systolic blood pressure \<90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<60 mmHg lasting more than 30 minutes at enrollment;
- Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment;
- An estimated PASP of \>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure;
- Acute kidney failure defined as an increase in serum creatinine to ≥4.0mg/dL (≥353.6 µmol/L) at enrollment;
- Evidence of contrast induced nephropathy, nephritis or nephrotic syndrome;
- Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT) or ultrafiltration in the last 90 days prior to enrollment;
- Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \> 1000U/L or total Bilirubin \> 5.0mg/dl) at enrollment;
- Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device;
- Prior heart transplant or likely heart transplantation before the 30- day follow-up visit;
- Current or previous support with a durable LVAD at any time or planned LVAD insertion before the 30-day follow-up visit;
- Use of an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g. Impella or TandemHeart) within the last 30 days;
- Confirmed diagnosis of AL amyloidosis;
- Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization in the next 30 days;
- Stroke within 30 days of enrollment;
- 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 7 days,
- GI bleeding within 6 months requiring hospitalization and/or transfusion,
- Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,
- Procedure with arterial ilio-femoral access \> 6 FR within 30 days,
- Platelet count \<75,000 cells/mm3,
- Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;
- Inability to tolerate anticoagulation therapy for up to 7 days.
- Descending aortic anatomy that would prevent safe placement of the device [\ 31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)],
- Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath,
- Femoral artery depth inconsistent with use of closure device,
- Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g.
- Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury,
- Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as...
- Known hypersensitivity or contraindication to study or procedure medications (e.g. anticoagulation therapy) or device materials (e.g. history of severe reaction to nickel or nitinol);
- Participation in any other clinical investigation that is likely to confound study results or affect the study;
- Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit;
- Currently admitted to the hospital with a primary diagnosis of decompensated HF, irrespective of ejection fraction (EF).
- Patient has already been evaluated and indicated to receive an LVAD or heart transplant and will receive the LVAD or be listed for heart transplantation in the next 30 days if their congestion status and renal function...
- Patient must have been treated with ≥ 80 mg IV furosemide bid or equivalent and have evidence of increasing diuretic dosing requirements over the past 12 months, as tolerated.
- Must have evidence of refractoriness to medical management as documented by persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water, or...
- Serum creatinine ≥ 2.0 mg/dL AND eGFR ≤ 45 ml/min/1.73m2 at time of enrollment
- Age ≥ 21 years and able to provide written informed consent.
- Treatment with high dose IV inotropes within 48 hours prior to enrollment. High dose is defined as any one of the following: \>5 µg/kg/min dopamine OR \>5 µg/kg/min dobutamine OR \>0.375 µg/kg/min milrinone.
- Active and ongoing hypotension with a systolic blood pressure \<80 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<55 mmHg lasting more than 30 minutes at enrollment.
- Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment.
- An estimated PASP of \>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure.
- Acute kidney failure defined as an increase in serum creatinine to ≥ 4.0mg/dL at enrollment.
- Evidence of contrast-induced nephropathy, nephritis, or nephrotic syndrome.
- Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT), or ultrafiltration in the last 90 days prior to enrollment.
- Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \> 1000U/L or total Bilirubin \> 5.0mg/dl) at enrollment.
- Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device.
- Current or previous support with a durable LVAD.
- INTERMACS Profile 1 at enrollment.
- Currently on mechanical ventilatory support.
- Use of an extracorporeal membrane oxygenation (ECMO) or percutaneous ventricular assist device (e.g., Impella or TandemHeart) within the last 30 days.
- Confirmed diagnosis of AL amyloidosis.
- Acute myocardial infarction Type 1 within 30 days of enrollment or planned coronary revascularization in the next 30 days.
- Stroke within 30 days of enrollment.
- 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 7 days.
- GI bleeding within 6 months requiring hospitalization and/or transfusion.
- Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding.
- Procedure with arterial ilio-femoral access \> 6 Fr within 30 days.
- Platelet count \<75,000 cells/mm3 .
- Uncorrectable bleeding diathesis or coagulopathy (e.g., INR≥ 2 not due to anticoagulation therapy) or hypercoagulable state including HIT.
- Inability to tolerate anticoagulation therapy for up to 7 days.
- Descending aortic anatomy that would prevent safe placement of the device [\ 31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)].
- Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21 Fr (outer diameter) introducer sheath.
- Femoral artery depth inconsistent with use of closure device.
- Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity
- Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury.
- Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as...
- Known hypersensitivity or contraindication to study or procedure medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol).
- Participation in any other clinical investigation that is likely to confound study results or affect the study.
- Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit.
- Unable or unwilling to undergo screening, device implant and retrieval procedures, or return for 30-day visit.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Concord, California, United States
- San Francisco, California, United States
- Fort Lauderdale, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Elk Grove Village, Illinois, United States
- Detroit, Michigan, United States
- Jackson, Mississippi, United States
- Hackensack, New Jersey, United States
- Neptune City, New Jersey, United States
- Brooklyn, New York, United States
- New York, New York, United States
- Poughkeepsie, New York, United States
- Staten Island, New York, United States
- Charlotte, North Carolina, United States
- Columbus, Ohio, United States
+ 7 more site(s).
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Concord, California, United States; San Francisco, California, United States; Fort Lauderdale, Florida, United States; Tampa, Florida, United States; Weston, Florida, United States and 21 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.