NCT05206422CompletedNot Applicable
DORAYA-HF: Assessment of the Doraya Catheter for the Treatment of Volume Overload in Acute Heart Failure Patients With Insufficient Response to Diuretics
Revamp Medical Inc.23 sites in 1 country21 target enrollmentStarted: October 5, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 23
- Primary Endpoint
- Serious Adverse Events
Study Overview
Brief Summary
The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is >18 years of age.
- •Subject is hospitalized with primary diagnosis of ADHF.
- •N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL for body-mass index (BMI) ≤
- •Evidence of fluid overload as indicated by 2 or more of the following criteria:
- •peripheral edema ≥ 2+
- •radiographic pulmonary edema or pleural effusion
- •enlarged liver or ascites
- •pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
- •Jugular venous distention > 7 cmH2O
- •IVCCI < 50% by cardiac ultrasonography or elevated CVP (or RAP) ≥12 mmHg (Invasively measured).
- •Subject insufficiently responds to IV diuretic therapy defined as average hourly urine output <125ml/hour over 6 hours OR cumulative urine output < 3L over 24 hours OR a Net Fluid Loss <375mL in a 12-hour timeframe following ≥2 diuretic challenges with a minimum of:
- •1st diuretic dose: ≥2X chronic oral daily dose (IV) or 80 mg IV Lasix or equivalent.
- •2nd diuretic dose: ≥ 80 mg IV Lasix or equivalent.
- •Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study. Females of child-bearing potential must have a negative pregnancy test.
- •Procedural Inclusion Criterion
- •CVP (or RAP) ≥12 mmHg and PCWP ≥ 18 mmHg confirmed in the Cath Lab, via femoral line, pigtail, Swan Ganz, or other indwelling catheter.
- •Systolic blood pressure <90 mmHg at the time of screening.
- •Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days.
- •Known LVEF < 10% by echocardiography within 1 year prior to enrollment.
- •Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
- •Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
- •Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \severe regurgitation) or Severe mitral disease with planned intervention.
- •Subject has severe renal dysfunction, defined as either eGFR <25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
- •Subject with advanced liver disease: either Total Bilirubin > 4 mg/dL or Serum sodium (corrected for glucose) < 125 mmol/L.
- •Treatment with high dose IV inotropes within 2 days prior to enrollment. High dose is defined as > 1 unit of inotrope (excluding Digoxin) as follows: 5 µg/kg/min dopamine = 1 unit, 5 µg/kg/min dobutamine= 1 unit, 0.375 µg/kg/min milrinone = 1 unit.
- •Subject with a history of:
- •Deep vein thrombosis that occurred < 6 months prior to enrollment, and/or;
- •Pulmonary embolism episode that occurred < 6 months prior to enrollment.
- •Evidence of active systemic infection documented by either one of the following: fever >38°C/100°F, or ongoing uncontrolled infection (i.e. inflammatory parameters not decreasing despite > 48 hrs of antibiotic treatment).
- •Subjects with a known infra-renal IVC diameter of <16mm.
- •Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.
Exclusion Criteria
- Not provided
Arms & Interventions
Control Arm
No Intervention
Diuretics only
Doraya Catheter
Experimental
Doraya Catheter with diuretics
Intervention: Doraya Catheter (Device)
Outcomes
Primary Outcomes
Serious Adverse Events
Time Frame: 30 days
Device or procedure related SAEs rate (including MACE) based on CEC adjudication.
Urine Output
Time Frame: baseline [pre intervention] and accumulated through 24 hours [T=0-24 hours]
Change in rate of urine output
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (23)
Loading locations...
Similar Trials
Completed
Not Applicable
DORAYA-HF OUS Assessment of the Doraya Catheter for the Treatment of ADHF Patients With Insufficient Response to DiureticsAcute Decompensated Heart FailureNCT05876078Revamp Medical Ltd.25
Completed
Not Applicable
First In Human Study of the Doraya Catheter for the Treatment of AHF PatientsAcute Heart FailureNCT03234647Revamp Medical Ltd.9
Recruiting
Not Applicable
EFS of the DUO System for Tricuspid RegurgitationTricuspid RegurgitationTricuspid Valve InsufficiencyHeart Valve DiseasesTricuspid Valve DiseaseNCT05913908CroiValve Limited15
Completed
Phase 2
Adenovirus Vascular Endothelial Growth Factor D (AdvVEGF-D) Therapy for Treatment of Refractory Angina PectorisRefractory Angina PectorisCoronary Artery DiseaseGene TransferNCT03039751Kuopio University Hospital63
Terminated
Not Applicable
Evaluation of the Safety and Clinical Performance of the Connected Catheter StudyChronicUrinary RetentionNCT05330598Spinal Singularity26