REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure

Recruiting

• Conditions: Cardiomyopathy; Heart Failure; 10019280

• Registration Number: NL-OMON52896
• Lead Sponsor: V-Wave Ltd.- Olivia Mishall

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Ischemic or non-ischemic cardiomyopathy with either reduced or preserved LV
ejection fraction and documented heart failure for at least 6 months from
baseline visit.
2.NYHA Class II, Class III or ambulatory Class IV HF (historical assessment
documented at the Baseline Screening visit).
3. Receiving guideline directed medical therapy (GDMT) for heart failure which
refers to those HF drugs carrying a Class I indication:
a) Patients with reduced LVEF (<=40%): An inhibitor of the renin-angiotensin
system (RAS inhibitor), including an angiotensin-converting enzyme (ACE)
inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor-
neprilysin inhibitor (ARNI) and a beta-blocker (BB), for at least 3 months
prior to the Baseline Visit.
b) Patients with reduced LVEF (<=40%): Other medications recommended for
selected populations, e.g., mineralocorticoid receptor antagonist (MRA) or
nitrates/hydralazine should be used in appropriate patients, according to the
published guidelines.
c) All patients: Patient has been on stable HF medications, as determined by
the investigator, for at least 1 month , with the exception of diuretic
therapy. Stable is defined as no more than a 100% increase or 50% decrease in
dose within these periods.
d) All patients: Drug intolerance, contraindications, or lack of indications
must be attested to by the investigator. Patients should be on appropriate
doses of diuretics as required for volume control.
4. Receiving Class I recommended cardiac rhythm management device therapy.
Specifically: if indicated by class I guidelines, cardiac resynchronization
therapy (CRT), implanted cardioverter-defibrillator (ICD) or a pacemaker should
be implanted at least 3 months prior to
Baseline Visit. These criteria may be waived if a patient is clinically
contraindicated for these therapies or refuses them and must be attested to by
the investigator.
5. NYHA Class II must meet both 5a AND 5b. NYHA Class III and ambulatory Class
IV must meet 5a OR 5b.
a) One (1) prior Heart Failure Hospitalization with duration >24 hours or
Emergency Room Heart Failure Visit with duration >=6 hours, or Heart Failure
Clinic ADHF Visit with duration >=6 hours, within 12 months from Baseline Visit.
i) If a CRT device was previously implanted, the heart failure hospitalization
must be >= 1 month after CRT implantation.
ii) If a mitral valve repair device (e.g. MitraClip) was previously implanted,
the heart failure hospitalization must be >= 1 month after mitral valve repair
implantation.
b) Alternatively, if patients have not had a HF hospitalization or ER HF Visit
within the prior 12 months, they must have a corrected elevated Brain
Natriuretic Peptide (BNP) level of at least 300 pg/ml or an N-terminal pro-BNP
(NT-proBNP) level of at least 1,500 pg/ml, according to local measurement,
within 3 months of the Baseline Visit during a clinically stable period and at
least 1 month after implantation of a CRT or mitral valve repair devices.
(Note: corrected refers to a 4% reduction in the BNP or NT-proBNP cutoff for
every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2). If patient
is on ARNI, NT-proBNP should be used exclusively.
6. Able to perform the 6-minute walk test with a distance >=100 meters and <=450
meters. The test will be per

Exclusion Criteria

1. Age <18 years old.
2. BMI >45 or <18 kg/m2.
3. Females of childbearing age who are not on contraceptives or surgically
sterile, pregnant or lactating mothers.
4. Resting systolic blood pressure <90 or >160 mmHg after repeated
measurements.
5. Baseline echocardiographic evidence of unresolved, non-organized or mobile
intracardiac thrombus.
6. Severe pulmonary hypertension defined as PA systolic pressure >70 mmHg by
echo/Doppler (or PVR >4.0 Wood Units by PA catheter measurement that cannot be
reduced to <=4 Wood Units by vasodilator therapy).
7. RV dysfunction defined as TAPSE <12mm or RVFAC <=25% as assessed on Baseline
TTE.
8. Left Ventricular End-Diastolic Diameter (LVEDD) >8cm as assessed on Baseline
TTE.
9. Atrial septal defect (congenital or iatrogenic), patent foramen ovale, or
anomalous pulmonary venous return, with more than trace shunting on color
Doppler or intravenous saline contrast (bubble study) or prior surgical or
interventional correction of congenital heart disease
involving the atrial septum (excluding closure by suture only but including
placement of a PFO or ASD closure device).
10. Untreated moderately severe or severe aortic or mitral stenosis.
11. Untreated severe or greater regurgitant valve lesions, which are
anticipated to require surgical or percutaneous intervention within 12 months.
12. Mitral valve repair device (e.g. MitraClip) implanted within 3 months prior
to Baseline Visit.
13. Untreated coronary stenosis which requires surgical or percutaneous
intervention.
14. Acute MI, acute coronary syndrome (ACS), percutaneous coronary intervention
(PCI), rhythm management system revision,(not including generator change) lead
extraction, or cardiac or other major surgery within 3 months of baseline
visit. Rhythm management system generator change within 1 month of Baseline
Visit.
15. Known active valvular vegetations, atrial myxoma, hypertrophic
cardiomyopathy with significant resting or provoked subaortic gradient, acute
myocarditis, tamponade, or large pericardial effusion,
constrictive pericarditis, infiltrative cardiomyopathy (including cardiac
sarcoidosis, amyloidosis, and hemochromatosis), or congenital heart disease, as
cause of HF.
16. Stroke, transient ischemic attack (TIA), systemic or pulmonary
thromboembolism, or deep vein thrombosis (DVT) within 6 months of Baseline
Visit. Any prior stroke with permanent neurologic deficit. Existing IVC
filter.
17. Transseptal procedure for another indication (e.g. AF ablation, left atrial
appendage occlusion, mitral valve repair/replacement) anticipated within 6
months.
18. Bradycardia with heart rate <45 bpm (unless treated with a permanent
pacemaker) or uncontrolled tachyarrhythmias. This includes defibrillation
shocks reported by the patient within 30 days from baseline visit.
19. Intractable HF with:
a) Resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D).
b) Treatment with IV vasoactive medications (e.g., IV inotropes, IV
vasodilators) within the last 30 days.
c) Cardiac Index <1.5 L/min/m2.
d) Treated with a ventricular assist device (VAD).
e) Listed for cardiac transplantation.
20. Prior cardiac transplantation.
21. Patients with HFrEF (LVEF <=40%) who are intolerant to a RAS inhibitor
including all of ACEI, AR

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Safety Endpoint:<br /><br><br /><br>The percentage of Treatment Group patients experiencing device-related Major<br /><br>Adverse Cardiovascular and Neurological Events (MACNE) during<br /><br>the first 30-days after randomization, compared to a pre-specified Performance<br /><br>Goal.<br /><br><br /><br>Primary Effectiveness Endpoint:<br /><br><br /><br>Comparison between Treatment and Control groups of the hierarchical composite<br /><br>ranking of all-cause death, cardiac transplantation or left ventricular assist<br /><br>device (LVAD) implantation, recurrent HF hospitalizations (including Emergency<br /><br>Room HF Visits with duration >=6 hours), recurrent worsening HF events treated<br /><br>as an outpatient (including ER visits < 6 hours), and change in KCCQ overall<br /><br>score. The analysis is based on the method of Finkelstein and Schoenfeld. </p><br>