Trials / Not Yet Recruiting
Not Yet RecruitingNCT06174623
Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
Early Feasibility Study to Mechanically Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Puzzle Medical Devices Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
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.
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
| Type | Name | Description |
|---|---|---|
| DEVICE | ModulHeart Support | The ModulHeart device will be implanted in the descending abdominal aorta. |
Timeline
- Start date
- 2024-08-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2023-12-18
- Last updated
- 2024-06-17
Locations
5 sites across 2 countries: Australia, Georgia
Source: ClinicalTrials.gov record NCT06174623. Inclusion in this directory is not an endorsement.