Heart FailureNCT06174623
Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
A study testing ModulHeart Support in people with Heart Failure and Acute Decompensated Heart Failure, run by Puzzle Medical Devices Inc. at 5 sites in 2 countries.
Trial summary
Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure, Acute Decompensated Heart Failure, Cardiorenal Syndrome
- What is being tested?
- ModulHeart Support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Georgia4 sites
Emergency Cardiology Center by Academician G. Chapidze
Tbilisi
Alexander Aladashvili, MD
Alexander Aladashvili, MD
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi
Irakli Gogorishvili, MD
Irakli Gogorishvili, MD
Tbilisi Heart and Vacular Clinic
Tbilisi
Tamaz Shaburishvili, MD
Tamaz Shaburishvili, MD
Tbilisi Heart Center
Tbilisi
Archil Chukhrukidze, MD
Archil Chukhrukidze, MD
Australia1 site
The Victorian Heart Hospital
Clayton, Victoria, 3168
Robert Gooley, MD, 03 9594 6666, robert.gooley@monashhealth.org
Robert Gooley, MD
About this study
Official title: Early Feasibility Study to Mechanically Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance
Read the detailed description
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.
- Conditions
- Heart Failure, Acute Decompensated Heart Failure, Cardiorenal Syndrome, Heart Failure, Congestive, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction
- Being tested
- ModulHeart Support
- Keywords
- Puzzle Medical Devices, ModulHeart, Mechanical Circulatory Support, Intra-Aortic, MCS, LVAD, pVAD, percutaneous ventricular assist device, Left ventricular assist device
- Medical subject headings
- Heart Failure, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModulHeart SupportDevice
The ModulHeart device will be implanted in the descending abdominal aorta.
| Study group | Role | What they receive |
|---|---|---|
| ModulHeart System | Experimental | Not described Receives: Device: ModulHeart Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE)
Measured: Baseline to 30-day Follow-Up
Technical success defined as successful device deployment, ability to deliver the treatment and remove the device
Measured: 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
Measured: Baseline to 1 day of ModulHeart-assisted decongestive therapy
Secondary outcomes (9)
Change in urine output
Measured: Baseline to end of ModulHeart therapy (up to 3 days)
Change in net fluid loss
Measured: Baseline to end of ModulHeart therapy (up to 3 days)
Change in natriuresis
Measured: Baseline to end of ModulHeart therapy (up to 3 days)
Change in creatinine clearance
Measured: Baseline to end of ModulHeart therapy (up to 3 days)
Change in N-terminal pro-B type natriuretic peptide (NT-pro BNP)
Measured: Baseline to end of ModulHeart therapy (up to 3 days)
Change in body weight
Measured: Baseline to end of ModulHeart therapy (up to 3 days)
Change in thermodilution cardiac output
Measured: Baseline to end of ModulHeart therapy (up to 3 days)
Change in right atrial pressure
Measured: Baseline to end of ModulHeart therapy (up to 3 days)
Change in mean pulmonary artery pressure
Measured: Baseline to end of ModulHeart therapy (up to 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study startAug 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puzzle Medical Devices Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174623
- Sponsor's protocol ID
- MH-ADHF-001
- Status last verified
- Jun 2024
- First submitted
- 30 Nov 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study to Mechanically Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
- ClinicalTrials.gov ID
- NCT06174623
- Acronym / sponsor ID
- MH-ADHF-001
- Conditions
- Heart Failure, Acute Decompensated Heart Failure, Cardiorenal Syndrome, Heart Failure, Congestive, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction
- Keywords
- Puzzle Medical Devices, ModulHeart, Mechanical Circulatory Support, Intra-Aortic, MCS, LVAD, pVAD, percutaneous ventricular assist device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Puzzle Medical Devices Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ModulHeart System | Experimental | Device: ModulHeart Support |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Diuretic resistance defined as at least ONE of the following:
Key exclusion criteria (39 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModulHeart SupportThe ModulHeart device will be implanted in the descending abdominal aorta. | Device | ModulHeart System |
Primary outcome
Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE)
Time frame: Baseline to 30-day Follow-Up
Technical success defined as successful device deployment, ability to deliver the treatment and remove the device
Time frame: 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
Time frame: Baseline to 1 day of ModulHeart-assisted decongestive therapy
9 secondary outcomes
Change in urine output
Time frame: Baseline to end of ModulHeart therapy (up to 3 days)
Change in net fluid loss
Time frame: Baseline to end of ModulHeart therapy (up to 3 days)
Change in natriuresis
Time frame: Baseline to end of ModulHeart therapy (up to 3 days)
Change in creatinine clearance
Time frame: Baseline to end of ModulHeart therapy (up to 3 days)
Change in N-terminal pro-B type natriuretic peptide (NT-pro BNP)
Time frame: Baseline to end of ModulHeart therapy (up to 3 days)
Change in body weight
Time frame: Baseline to end of ModulHeart therapy (up to 3 days)
Change in thermodilution cardiac output
Time frame: Baseline to end of ModulHeart therapy (up to 3 days)
Change in right atrial pressure
Time frame: Baseline to end of ModulHeart therapy (up to 3 days)
Change in mean pulmonary artery pressure
Time frame: Baseline to end of ModulHeart therapy (up to 3 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ModulHeart Support in people with Heart Failure and Acute Decompensated Heart Failure, run by Puzzle Medical Devices Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Georgia, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Georges (514-758-8971, gabriel.georges@puzzlemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE) (time frame: Baseline to 30-day Follow-Up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.