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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06174623




Registration number
NCT06174623
Ethics application status
Date submitted
30/11/2023
Date registered
18/12/2023
Date last updated
17/04/2024

Titles & IDs
Public title
Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
Scientific title
Early Feasibility Study to Mechanically Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
Secondary ID [1] 0 0
MH-ADHF-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Acute Decompensated Heart Failure 0 0
Cardiorenal Syndrome 0 0
Heart Failure, Congestive 0 0
Heart Failure With Preserved Ejection Fraction 0 0
Heart Failure With Reduced Ejection Fraction 0 0
Diuretic Resistance 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ModulHeart Support

Experimental: ModulHeart System -


Treatment: Devices: ModulHeart Support
The ModulHeart device will be implanted in the descending abdominal aorta.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE)
Timepoint [1] 0 0
Baseline to 30-day Follow-Up
Primary outcome [2] 0 0
Technical success defined as successful device deployment, ability to deliver the treatment and remove the device
Timepoint [2] 0 0
Baseline to 30-day Follow-Up
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline to 1 day of ModulHeart-assisted decongestive therapy
Secondary outcome [1] 0 0
Change in urine output
Timepoint [1] 0 0
Baseline to end of ModulHeart therapy (up to 3 days)
Secondary outcome [2] 0 0
Change in net fluid loss
Timepoint [2] 0 0
Baseline to end of ModulHeart therapy (up to 3 days)
Secondary outcome [3] 0 0
Change in natriuresis
Timepoint [3] 0 0
Baseline to end of ModulHeart therapy (up to 3 days)
Secondary outcome [4] 0 0
Change in creatinine clearance
Timepoint [4] 0 0
Baseline to end of ModulHeart therapy (up to 3 days)
Secondary outcome [5] 0 0
Change in N-terminal pro-B type natriuretic peptide (NT-pro BNP)
Timepoint [5] 0 0
Baseline to end of ModulHeart therapy (up to 3 days)
Secondary outcome [6] 0 0
Change in body weight
Timepoint [6] 0 0
Baseline to end of ModulHeart therapy (up to 3 days)
Secondary outcome [7] 0 0
Change in thermodilution cardiac output
Timepoint [7] 0 0
Baseline to end of ModulHeart therapy (up to 3 days)
Secondary outcome [8] 0 0
Change in right atrial pressure
Timepoint [8] 0 0
Baseline to end of ModulHeart therapy (up to 3 days)
Secondary outcome [9] 0 0
Change in mean pulmonary artery pressure
Timepoint [9] 0 0
Baseline to end of ModulHeart therapy (up to 3 days)

Eligibility
Key inclusion criteria
1. Admitted to the hospital with a primary diagnosis of ADHF

2. 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

3. 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)

4. Appropriate intravenous loop diuretic therapy at the time of enrollment, defined as at
least the higher of:

1. Furosemide 40mg IV bid or equivalent

2. IV furosemide or equivalent IV loop diuretic equivalent to =2x the total oral
daily loop diuretic dose at home in 2 divided doses

5. Diuretic resistance defined as at least ONE of the following:

1. Urine output of less than 1.5L over 12h following the last diuretic dose, OR

2. Net fluid loss of less than 1L over the last 24 hours, OR

3. 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

4. Clinically unsatisfactory resolution of congestion

6. Age = 21 years old

7. Signed informed consent
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ADHF related to acute secondary disease (i.e., infection or acute coronary syndrome)

2. 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

3. 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

4. Recent myocardial infarction, percutaneous coronary intervention or surgical
revascularization (within the last 3 months) or awaiting planned coronary intervention
or surgery

5. 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

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

7. Reanimated cardiac arrest in the last 30 days

8. Suspected or known amyloid disease or other restrictive cardiomyopathy

9. Severe bleeding risk precluding anticoagulation:

1. 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

2. Gastrointestinal (GI) bleeding within 1 month requiring hospitalization and/or
transfusion

3. Recent major surgery within 1 month if the surgical wound is judged to be
associated with an increased risk of bleeding

4. Platelet count of less than 50,000 cells/mm3

5. Uncorrectable bleeding diathesis or coagulopathy

10. Contraindicated anatomy:

1. 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)

2. Abnormalities of the aorta or subclavian or axillary arteries that would prevent
safe device placement, including aneurysms, significant tortuosity, or
calcifications

3. Axillary artery anatomy that would preclude safe placement of a 10F sheath
including severe obstructive calcification or severe tortuosity

4. Iliofemoral artery anatomy that would preclude safe placement of a 16F introducer
sheath including severe obstructive calcification or severe tortuosity

5. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at
risk of vascular injury

6. Prior endovascular surgery or percutaneous intervention involving the
thoracoabdominal aorta or a subclavian/axillary artery or history of aortic
dissection

11. Severe aortic stenosis

12. Known or suspected contrast induced nephropathy

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

14. 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

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

16. Presence of any one of the following risk factors for indications of severe end organ
dysfunction or failure:

1. Liver disease (cirrhosis of the liver [Child-Pugh class B or C]) or shock liver

2. History of severe chronic obstructive pulmonary disease (COPD) defined by
FEV1/FVC less than 0.7, and FEV1 less than 50% predicted

3. 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

17. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation

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

19. Active infection not controlled with antibiotic therapy

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

21. Body mass index (BMI) over 40 kg/m2

22. Estimated life expectancy of less than 6 months

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

24. 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

25. 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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Puzzle Medical Devices Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with
acute decompensated heart failure (ADHF) and diuretic resistance
Trial website
https://clinicaltrials.gov/ct2/show/NCT06174623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gabriel Georges
Address 0 0
Country 0 0
Phone 0 0
514-758-8971
Fax 0 0
Email 0 0
gabriel.georges@puzzlemed.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06174623