NCT04227977

Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: 3ive Labs · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. The aims and purpose of this feasibility clinical research trial are: 1. to evaluate the safety profiles associated with performing negative pressure diuresis for the treatment of hypervolemia associated with the cardiorenal syndrome during ADHF with persistent congestion despite high dose IV diuretic therapy via the investigational JuxtaFlow® System, and 2. to evaluate the effectiveness of the investigational JuxtaFlow System in treatment of hypervolemia associated with ADHF.

Detailed description

The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. The primary renal adjuvant therapies for presistent congestion despite high dose IV diuretic therapy are ultrafiltration and dialysis. Unfortunately, clinical decongestion is uncommon in this population despite aggressive therapies. Negative pressure diuresis in the renal pelvis has the potential to treat hypervolemia associated with ADHF by increasing renal filtration and increased urine output. Primary endpoint: The characterization of the type, frequency, severity, and device-relatedness of adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System and a 28-day post-treatment actuarial follow up. Secondary endpoints: a) Increase in urine output from baseline to discontinuation of treatment with the JuxtaFlow System. b) Reduction of congestion (as measured by change in BNP) during the course of the treatment with the JuxtaFlow System. c) The relative change in creatinine clearance from baseline to treatment period after 24 hours of treatment or until discontinuation of the investigational treatment using each study subject as their own control. The change in creatinine clearance from the baseline period to the 24 hour post End of Treatment (EOT) period.

Conditions

• Cardiorenal Syndrome

Interventions

Type	Name	Description
DEVICE	JuxtaFlow System	The JuxtaFlow System consists of proprietary ureteral catheters deployed endoscopically over the wire to deliver mild controlled negative pressure into the renal pelvis.

Timeline

• Start date: 2020-06-12
• Primary completion: 2023-05-01
• Completion: 2023-10-20
• First posted: 2020-01-14
• Last updated: 2023-10-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study