- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06174623
Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
April 15, 2024 updated by: Puzzle Medical Devices Inc.
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gabriel Georges
- Phone Number: 514-758-8971
- Email: gabriel.georges@puzzlemed.com
Study Contact Backup
- Name: Maxime Rochon
- Phone Number: 514-292-7271
- Email: maxime.rochon@puzzlemed.com
Study Locations
-
-
Victoria
-
Clayton, Victoria, Australia, 3168
- The Victorian Heart Hospital
-
Principal Investigator:
- Robert Gooley, MD
-
Contact:
- Robert Gooley, MD
- Phone Number: 03 9594 6666
- Email: robert.gooley@monashhealth.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 3 months) 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
- Estimated life expectancy of less than 6 months
- 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
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?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ModulHeart System
|
The ModulHeart device will be implanted in the descending abdominal aorta.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE)
Time Frame: Baseline to 30-day Follow-Up
|
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
|
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
|
Baseline to 1 day of ModulHeart-assisted decongestive therapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in urine output
Time Frame: Baseline to end of ModulHeart therapy (up to 3 days)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
Baseline to end of ModulHeart therapy (up to 3 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
November 30, 2023
First Submitted That Met QC Criteria
December 7, 2023
First Posted (Actual)
December 18, 2023
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH-ADHF-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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