Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
NCT06174623 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2024-06-17
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
Interventions
- DEVICE
-
ModulHeart Support
The ModulHeart device will be implanted in the descending abdominal aorta.
Sponsors & Collaborators
-
Puzzle Medical Devices Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-31
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- Australia
- Georgia
Study Locations
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