Optimal Balance Alfapump® System Feasibility Study

NCT03032211 | Withdrawn Phase 1 DMC

• 1 other identifier: 2016-CHF-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

1. 1.Primary Objective
2. 2.Study Endpoints
3. 3.Primary Safety Endpoint
4. 4.Surgical implant of the alfapump®
5. 5.Device malfunctions
6. 6.Dialysate infusion
7. 7.Secondary Safety Endpoints
8. 8.Time to first hospitalization related to fluid management after the activation of the alfapump® System and initiation of dialysate infusion has occurred
9. 9.Rate of occurrence of re-hospitalizations related to fluid management
10. 10.All-cause mortality
11. 11.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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events (AEs) and serious adverse events (SAEs)

  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.

  Q1 2017 and Q3 2017

Study Arms (1)

Treatment

EXPERIMENTAL

Alfapump

Device: Alfapump

Interventions

Alfapump DEVICE

Implant Alfapump® System

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 18 years and \< 80 years of age
• Patients exhibiting physical signs of excessive fluid retention (i.e. elevated JVD, peripheral edema, ascites, pulmonary edema, weight gain etc.)
• Patients with an eGFR by the Modification of Diet in Renal Disease (MDRD) of \> 15 to \< 60 mL/min/1.73m2
• Patients with a brain natriuretic peptide (BNP) ≥ 150 pg/mL and/or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥ 600 pg/mL at time of screening or BNP ≥ 100 pg/mL and/or NTproBNP ≥ 400 pg/mL
• Patients who have a Six Minute Walk Test (SMWT) exercise capacity between 100 and 400 meters
• Patients presenting with NYHA Class III or ambulatory NYHA Class IV heart failure who have been on optimal medical management (OMM) based on current heart failure practice guidelines and who are failing to respond to or cannot tolerate one or more of the following interventions:
• Treatment with diuretic therapy
• Treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for at least 30 days
• Treatment with nitrates and/or vasodilators at the investigator's discretion
• Treatment with beta-blockers for at least 90 days
• Treatment with cardiac resynchronization therapy (CRT)
• Treatment with an automatic implantable cardioverter defibrillator (AICD)
• Patients who demonstrate compliance with the current medical regimen as reported by the treating physician

You may not qualify if:

• Patients presenting with acute decompensated heart failure requiring hospitalization for management of their symptoms (i.e. hospitalization for exacerbation of chronic heart failure manifested by signs and symptoms requiring intravenous and/or more aggressive therapy)
• Patients with ascites on physical examination resulting predominantly from right heart failure
• Patients who have an indication for and are candidates for CRT but who have not been treated with CRT
• Patients who have an indication for and are candidates for an AICD but who have not been implanted with an AICD
• Patients with reversible causes of heart failure which may be remedied by conventional surgery or other interventions
• Patients with an eGFR by MDRD \< 15 or \> 60 ml/min/1.73m2
• Patients with a body mass index (BMI) \< 18 kg/m2or \> 35 kg/m2
• Patients with severe pulmonary disease by history (i.e. severe chronic obstructive pulmonary disease, severe hypoxia or a pulmonary artery mean pressure \>40 mm Hg)
• Patients who have experienced a myocardial infarction (MI) within the past 90 days
• Patients who have experienced a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 90 days
• Patients who have undergone cardiac surgery or other major surgery within the past 90 days
• Patients who are candidates for and require a concomitant surgical procedure \[i.e. coronary artery bypass graft (CABG), valvular surgery, etc.
• Patients who are candidates for and require temporary or durable mechanical circulatory support \[i.e. intra-aortic balloon pump (IABP), ventricular assist device (VAD), extracorporeal membrane oxygenation (ECMO)\]
• Patients with confirmed untreated abdominal aortic aneurysm (AAA) \> 5 cm in diameter diagnosed within the past six months
• Patients with active systemic or uncontrolled infections

Sponsors & Collaborators

• Sequana Medical N.V.: lead

Study Sites (1)

Military Hospital - State Health Centre

Budapest, 1134, Hungary

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: • 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.

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: January 26, 2017
• Study Start: December 31, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 22, 2021

Record last verified: 2018-04

Locations

HU (1)