Acute Heart FailureTRVDNCT03621436
Clinical Evaluation of the TRVD™ System in ADHF
A study testing TRVD Therapy in people with Acute Heart Failure and Congestive Heart Failure, run by Magenta Medical Ltd. at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Congestive Heart Failure, Heart Failure, Congestive
- What is being tested?
- TRVD Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 7 Aug 2015to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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.
- Being tested
- TRVD Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRVD TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TRVD Therapy | Experimental | Not described Receives: Device: TRVD Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary Safety (device- and procedure-related SAEs)
Incidence of device- and procedure-related SAEs
Measured: 30 days post index procedure
Feasibility (technical success)
Rate of technical success (defined as successful delivery and deployment, adequate function during device operation and successful retrieval) at hospital discharge.
Measured: Hospital discharge (at least 96 hours following index procedure)
Feasibility (procedural success)
Rate of procedural success (defined as absence of device-related SAEs) at hospital discharge.
Measured: Hospital discharge (at least 96 hours following index procedure)
Secondary outcomes (1)
Initial performance (effectiveness of renal venous pressure reduction)
Invasively assessed renal venous pressure reduction from baseline (in mmHg)
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start7 Aug 2015
- Primary completionApr 2019
- Study completionMay 2019
Why it stopped: Study was terminated due to sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magenta Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621436
- Sponsor's protocol ID
- DRD00202, DRD00208, DRD00214
- Acronym
- TRVD
- Status last verified
- Aug 2019
- First submitted
- 14 Jun 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Transcatheter Renal Venous Decongestion (TRVD™) System for Renal Venous Decongestion in Patients With Acute Decompensated Heart Failure (ADHF)
- ClinicalTrials.gov ID
- NCT03621436
- Acronym / sponsor ID
- TRVD / DRD00202, DRD00208, DRD00214
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to sponsor decision
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Magenta Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRVD Therapy | Experimental | Device: TRVD Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 .
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRVD TherapyA 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. | Device | TRVD Therapy |
Primary outcome
Preliminary Safety (device- and procedure-related SAEs)
Time frame: 30 days post index procedure
Incidence of device- and procedure-related SAEs
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.
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.
1 secondary outcome
Initial performance (effectiveness of renal venous pressure reduction)
Time frame: Up to 24 hours
Results and safety
The study was stopped early (reason given: Study was terminated due to sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRVD Therapy in people with Acute Heart Failure and Congestive Heart Failure, run by Magenta Medical Ltd. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Croatia, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary Safety (device- and procedure-related SAEs) (time frame: 30 days post index procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.