Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance

NCT06174623 | Not Yet Recruiting DMC

• 1 other identifier: MH-ADHF-001
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 5

Brief Summary

Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance

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

Keywords

Puzzle Medical Devices; ModulHeart; Mechanical Circulatory Support; Intra-Aortic; MCS; LVAD; pVAD; percutaneous ventricular assist device; Left ventricular assist device

Outcome Measures

Primary Outcomes (3)

• Device safety defined as freedom from serious in-hospital procedure or device-related adverse event (AE)

  Baseline to 30-day Follow-Up

• Technical success defined as successful device deployment, ability to deliver the treatment and remove the device

  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

  Baseline to 1 day of ModulHeart-assisted decongestive therapy

Secondary Outcomes (9)

• Change in urine output

  Baseline to end of ModulHeart therapy (up to 3 days)

• Change in net fluid loss

  Baseline to end of ModulHeart therapy (up to 3 days)

• Change in natriuresis

  Baseline to end of ModulHeart therapy (up to 3 days)

• Change in creatinine clearance

  Baseline to end of ModulHeart therapy (up to 3 days)

• Change in N-terminal pro-B type natriuretic peptide (NT-pro BNP)

  Baseline to end of ModulHeart therapy (up to 3 days)

Study Arms (1)

ModulHeart System

EXPERIMENTAL

Device: ModulHeart Support

Interventions

ModulHeart Support DEVICE

The ModulHeart device will be implanted in the descending abdominal aorta.

ModulHeart System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Puzzle Medical Devices Inc.: lead

Study Sites (5)

The Victorian Heart Hospital

Clayton, Victoria, 3168, Australia

Location

Emergency Cardiology Center by Academician G. Chapidze

Tbilisi, Georgia

Location

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Location

Tbilisi Heart and Vacular Clinic

Tbilisi, Georgia

Location

Tbilisi Heart Center

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Heart Failure; Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Gabriel Georges

CONTACT

514-758-8971; gabriel.georges@puzzlemed.com

Maxime Rochon

CONTACT

514-292-7271; maxime.rochon@puzzlemed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 18, 2023
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GE (4); AU (1)