Optimal Balance Alfapump® System Feasibility Study (OPTIMALBALANCE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03032211|
Recruitment Status : Withdrawn (Change in company strategy)
First Posted : January 26, 2017
Last Update Posted : March 22, 2021
1. Summary of Clinical Investigation
A summary of the clinical investigation is provided below and includes the primary objective of the study, the safety and feasibility endpoints, the number of subjects to be enrolled, the study duration, the subject follow-up and the inclusion/exclusion criteria.
The primary objective of the study is to evaluate the safety and feasibility of the alfapump® System indication for use in the management of fluid in NYHA Class III and ambulatory NYHA Class IV heart failure patients who have an eGFR of > 15 to < 60 mL/min/1.73m2.
Primary Safety Endpoint
The primary safety endpoint will be an assessment of the occurrence of adverse events (AEs) and serious adverse events (SAEs) related to:
- Surgical implant of the alfapump®
- Device malfunctions
- Dialysate infusion
Secondary Safety Endpoints
The secondary endpoint will be an assessment of:
- Time to first hospitalization related to fluid management after the activation of the alfapump® System and initiation of dialysate infusion has occurred
- Rate of occurrence of re-hospitalizations related to fluid management
- All-cause mortality
- Assessment of Feasibility for Fluid Management in Heart Failure Indication The feasibility of the alfapump® System for management of fluid in NYHA Class III and ambulatory NYHA Class IV heart failure patients with renal dysfunction will be assessed by the net fluid balance as measured by the ability of the alfapump® System to move more fluid to the bladder than dialysate instilled.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Alfapump||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||• Prospective, non-randomized, open label, single-arm study to evaluate the safety and feasibility of the use of the alfapump® system in New York Heart Association (NYHA) Class III and ambulatory NYHA Class IV heart failure patients with a history of at least one hospitalization for fluid management within the previous year.|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Clinical Study of Osmotic Pump Treatment in Fluid Management to Achieve Optimal Fluid Balance in NYHA Class III and Ambulatory NYHA Class IV Heart Failure Patients Who Have an Estimated Glomerular Filtration Rate of > 15 to < 60 mL/Min/1.73m2|
|Estimated Study Start Date :||December 31, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Implant Alfapump® System
- Occurrence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Q1 2017 and Q3 2017 ]4 weeks after the third patient implanted an initial safety review will be done and after the last patient completed 3 months of dialysate administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032211
|Military Hospital - State Health Centre|
|Budapest, Hungary, 1134|