- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03621436
Clinical Evaluation of the TRVD™ System in ADHF (TRVD)
Clinical Evaluation of the Transcatheter Renal Venous Decongestion (TRVD™) System for Renal Venous Decongestion in Patients With Acute Decompensated Heart Failure (ADHF)
A prospective, multi-national, open-label clinical study which is conducted to asses the safety, feasibility and performance of the TRVD™ System in hospital-admitted patients with Acute Decompensated Heart Failure (ADHF) and evidence of reduced left ventricular ejection fraction.
The study will include patients who present with significant venous congestion, as evidenced by clinical, laboratory and imaging signs of fluid retention.
Study participation, for each enrolled subject, will last approximately 3 months post index procedure.
Patients will be evaluated from enrollment until hospital discharge, then at 30, 60, and 90 days post procedure.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient is 18 years of age or older
- Patient admitted to the hospital with a primary diagnosis of ADHF who is chronically treated with at least one oral loop diuretic.
- Patient presents at least two of the following clinical signs of manifest volume overload: 3.1 Jugular venous distension 3.2 Dyspnea, rales, or evidence of pulmonary congestion or oedema on admission chest radiography 3.3 Abdominal discomfort compatible with internal organ congestion and/or hepatomegaly 3.4 Peripheral oedema
- Ultrasonic evidence of IVC plethora, defined as IVC diameter >2.0 cm.
- BNP levels >300 pg/dL or NT-proBNP >1500 pg/dL .
- Evidence of cardiac etiology as per cardiac ultrasonography.
- LVEF =/<40%.
- CVP (Invasively measured) >/=14 mmHg
- Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test).
- Patient understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
Exclusion Criteria:
- INR >3, use of a NOAC in the past 48 hours or contraindication to systemic anticoagulation with Heparin.
- Evidence of hemodynamic instability, evidence of shock with organ hypoperfusion, or need for inotropic support.
- Overt pulmonary oedema, or Respiratory insufficiency/hypoxia (peripheral haemoglobin saturation <90% with supplemental oxygen), need for non-invasive positive pressure ventilation or intubation.
- Severe renal dysfunction (eGFR before decompensation <45 ml/min/1.73 m2 BSA or <25 on admission).
- Known renal artery stenosis.
- Known intrinsic kidney disease (e.g., established diagnosis of diabetic nephropathy with macroproteinuria, chronic glomerulonephritis).
- Severe anaemia (haemoglobin <9 mg/dL).
- Thrombocytopenia with a platelets count <100,000.
- Acute coronary syndrome within 4 weeks prior to admission.
- Active myocarditis or hypertrophic obstructive cardiomyopathy.
- Complex congenital heart disease.
- Severe valvular stenosis.
- Severe morbid obesity (BMI >35).
- Fluid retention that is not primarily of cardiac origin (e.g., advanced liver disease, severe hypo-albuminaemia, etc.)
- Temperature > 38°C (oral or equivalent), or sepsis, or active systemic infection requiring IV anti-microbial treatment.
- Large ascites per ultrasound/CT.
- Cognitive impairment.
- Planned PCI, or more than minor surgery in the next 3 months.
- Moribund patient, or patient with malignancy or other comorbidities limiting life expectancy to less than one year.
- Patient has a known allergy to Nickel.
- Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication.
- Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TRVD Therapy
|
A catheter-mounted expandable flow pump is to be deployed in a transfemoral venous catheterization procedure.
Once in place, renal venous pressure is reduced to a pre-selected physiologic target pressure and kept there for up to 24 hours.
After termination of TRVD therapy, the device is removed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preliminary Safety (device- and procedure-related SAEs)
Time Frame: 30 days post index procedure
|
Incidence of device- and procedure-related SAEs
|
30 days post index procedure
|
Feasibility (technical success)
Time Frame: Hospital discharge (at least 96 hours following index procedure)
|
Rate of technical success (defined as successful delivery and deployment, adequate function during device operation and successful retrieval) at hospital discharge.
|
Hospital discharge (at least 96 hours following index procedure)
|
Feasibility (procedural success)
Time Frame: Hospital discharge (at least 96 hours following index procedure)
|
Rate of procedural success (defined as absence of device-related SAEs) at hospital discharge.
|
Hospital discharge (at least 96 hours following index procedure)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial performance (effectiveness of renal venous pressure reduction)
Time Frame: Up to 24 hours
|
Invasively assessed renal venous pressure reduction from baseline (in mmHg)
|
Up to 24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DRD00202, DRD00208, DRD00214
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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