Status:
COMPLETED
Alfapump Direct Sodium Removal (DSR) Feasibility Study
Lead Sponsor:
Sequana Medical N.V.
Collaborating Sponsors:
Yale University
Conditions:
Heart Failure
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
First in Human feasibility and sfafety study of the alfapump DSR system in the treatment of Heart failure subects resistant to diuretic therapy. Up to 10 subjects will be enrolled in up to 3 centres i...
Detailed Description
Up to 10 subjects diagnosed with stable chronic heart failure (CHF) on high oral diuretic dose and an MDRD eGFR \> 30ml/min/1.73m2 will undergo subcutaneous implantation of the alfapump DSR system (Da...
Eligibility Criteria
Inclusion
- Subjects \> 18 years of age
- eGFR \> 30ml/min/14.73m2
- Diagnosis of heart failure with one of the following: a. nt-proBNP \> 400 pg/ml (or BNP \> 100 pg/mp) and oral diuretic dose ≥ 80mg furosemide (or 20mg torsemide or 1mg bumetanide) OR b. Oral diuretic dose ≥ 120mg furosemide (or 30 mg torsemide or 1.5 mg bumetanide)
- Stable diuretic dose for 30 days
- Systolic blood pressure ≥ 100 mmHg
- Determined by treating provider to be at optimal volume status
Exclusion
- Candidates for participation will be ineligible for the study if any of the following exclusion criteria apply:
- Proteinuria \> 1g/day
- BMI \> 40
- History of abdominal surgery or peritonitis
- Anemia with hemoglobin \< 8g/dL
- Serum sodium \< 135 mEq/L
- Severe hyperkalemia or baseline plasma potassium \> 4.5 mEq/L
- Significant other organ disease or comorbidities
- Hospitalization within 90 days
- Cirrhosis
- Hemodynamically significant stenotic valvular disease
- Active or recurrent urinary tract infection or history of renal transplant
- History of significant bladder dysfunction expected to interfere with ability of subject to tolerate DSR pumping into bladder
- Uncontrolled diabetes with frequent hyperglycemia or Type 1 diabetes
- Subject is currently participating in another clinical trial
- Subject is unable to comply with all required study follow-up procedures
Key Trial Info
Start Date :
December 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04116034
Start Date
December 26 2019
End Date
April 15 2021
Last Update
May 28 2021
Active Locations (2)
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1
OLV Ziekenhuis
Aalst, Belgium, 9300
2
Tbilisi Heart & Vascular Clinic
Tbilisi, Georgia