V-Lap System For Wirelessly Measuring And Monitoring Left Atrial Pressure (LAP) In Patients With Advance Chronic Heart Failure

Inclusion Criteria:

1. Ischemic or non-ischemic cardiomyopathy and documented heart failure for atleast 6 months (diagnosis of HF ≥ 6 months), regardless of ejection fraction.

2. NYHA Class II heart failure (HF) subjects, documented at Baseline Visit regardlessof ejection fraction, meeting both inclusion criteria in subsections (2a) and (2b)or NYHA Class III heart failure (HF) subjects, documented at Baseline Visitregardless of ejection fraction, meeting at least one inclusion criteria insubsections (2a) and (2b).

3. Have a minimum of one (1) HF hospitalization or equivalent (HF Emergency DepartmentVisit or HF Urgent Clinic Visit) within the last 12 months associated withsigns/symptoms of congestion requiring treatment with intravenous (IV) diuretic. IfCardiac Resynchronization Therapy (CRT) device previously implanted, the HFhospitalization or equivalent must be ≥ 30 days after CRT implantation.

4. Have a corrected* elevated outpatient Brain Natriuretic Peptide (BNP) level of atleast 300 pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500 pg/ml,according to local measurement, within 90-days of the Baseline Visit.

*Thresholds for NT-proBNP will be corrected for body mass index (BMI) using a 4%reduction per BMI unit over 20 kg/m2. If subject is on ARNI, NT-proBNP should beused exclusively.

3. Receiving maximally-tolerated medical therapy for heart failure as indicatedper ACC/AHA or ESC Heart Failure Guidelines (guideline-directed medical therapyor GDMT), in the absence of contraindications and lack of availability. GDMTrefers to those guideline-directed medical therapies having a Class Iindication for use.

• For patient with heart failure and a reduced ejection fraction (HFrEF), GDMTincludes a diuretic as needed for volume control, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptorneprilysin inhibitor (ARNI), beta-blocker (BB), mineralocorticoid receptorantagonist (MRA), and SGLT2 inhibitor for at least 3 months prior to theBaseline visit. Drug doses, with the exception of diuretics, should be stablefor at least 1 month, where stability is defined as no more than a 100%increase or 50% decrease in dose.

• For patient with heart failure and a preserved ejection fraction (HFpEF), GDMTincludes a diuretic as needed for volume control and treatment of associatedconditions (e.g., hypertension, atrial fibrillation) for at least 3 monthsprior to the Baseline visit. Drug doses, with the exception of diuretics,should be stable for at least 1 month, where stability is defined as no morethan a 100% increase or 50% decrease in dose.

• Patients should also receive Class I recommended cardiac rhythm managementdevice therapy. Specifically: if indicated by class I guidelines, cardiacresynchronization therapy (CRT), implanted cardioverter-defibrillator (ICD), ora pacemaker should be implanted at least 3 months prior to Baseline Visit.These criteria may be waived if a patient is clinically contraindicated forthese therapies or refuses them and must be attested to by the investigator.

• GDMT may change over time; the most current versions of the ACC/AHA or ESCHeart Failure Guidelines will supersede the above guidelines.

4. Provide informed consent for study participation and be willing and ableto comply with the required tests, treatment instructions, and follow-upvisits.

Exclusion Criteria:

1. Age less than 22 (<22) or greater than 88 (>88) years old. 2. Subjects whoare NYHA class IV and ACC/AHA stage D. 3. Subjects with evidence/historyof a major cardiovascular or neurovascular event, such as an intra-cardiacthrombus or history of stroke, transient ischemic attack, systemic orpulmonary thromboembolism, deep vein thrombosis (DVT), within the last 6months of Baseline Visit.
2. Subjects with a resting systolic blood pressure <90 or >180 mmHg. 5. Leftventricular end-diastolic diameter (LVEDD) > 8cm. 6. Have an atrial septaldefect or patent foramen ovale with more than trace shunting on colorDoppler or intravenous bubble study or surgical or interventionalcorrection of congenital heart disease involving atrial septum, includingplacement of a PFO or ASD closure device, and have a hypermobile septum ora septal aneurysm.
3. Subjects with untreated severe valve lesions, which are indicated forsurgical or percutaneous intervention, active valvular vegetations, atrialmyxoma, hypertrophic cardiomyopathy with significant resting or provokedsubaortic gradient, acute myocarditis, tamponade, or large pericardialeffusion, constrictive pericarditis, infiltrative cardiomyopathy (including cardiac sarcoidosis, amyloidosis, and hemochromatosis), orcongenital heart disease, as a cause of HF.
4. Uncontrolled tachyarrhythmia or bradycardia (heart rate <45). 9.Intractable HF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D), including subjects receiving continuous orintermittent outpatient IV vasoactive medications (e.g., IV inotropes, IVvasodilators), subjects treated with a ventricular assist device (VAD).
5. Intolerant to ACE-I, ARB, or ARNI and beta-blocker medical therapy forsubjects classified as HFrEF (EF ≤40%).
6. The presence of an acute coronary syndrome (ACS), percutaneous coronaryintervention (PCI), rhythm management system revision, lead extraction, orcardiac or other major surgery within the preceding 90 days.
7. Subjects not eligible for emergency open-heart, thoracic or vascularsurgery.
8. Women of childbearing age. 14. Subjects with a life expectancy that isshorter than 12 months, or those who have received a cardiac transplant orare listed for cardiac transplantation and likely to be transplantedwithin 12 months of Baseline Visit.
9. Have coagulopathy or uninterruptible anticoagulation therapy orcontraindication for all the forms of antiplatelet/anticoagulanttreatments anticipated in the protocol.
10. Known history of life-threatening allergy to contrast dye that cannot beproperly pre-medicated.
11. Have an estimated Glomerular Filtration Rate (GFR) <20 ml/min/1.73 m2 bythe MDRD method or on chronic renal dialysis.
12. Hepatic impairment with at least one liver Function Test (transaminases,total bilirubin, or alkaline phosphatase) ≥ 3 times upper limit of normal.
13. Gastrointestinal bleeding in the last 6 months. 20. Have severe chronicpulmonary disease requiring continuous home oxygen, chronic oral steroidtherapy, hospitalization for exacerbation during prior 6 months, or hassevere obstructive physiology on PFTs (FEV1/FVC <0.70 and FEV1 < 50%normal), if done.
14. Subjects who have an active infection requiring systemic antibiotics or anelevated white blood count (above the local laboratory reference ranges).
15. Have a history of active drug addiction, active alcohol abuse, orpsychiatric hospital admission for psychosis within the prior 2 years.
16. Are currently participating in a clinical study or investigation. 24.Subject otherwise not appropriate for study as determined by theinvestigator and subjects who are unwilling to comply with the studyprotocol, or subjects with a history of non-compliance. The reasons mustbe documented.
17. Subjects contraindicated for trans-septal puncture, TEE or ICE. Intra Procedural Exclusion Criteria:

(Intra Procedural Exclusion Criteria will be determined immediately afterintracardiac echocardiography or transesophageal echocardiography determination ofleft atrial anatomy and just before transseptal puncture) 26. Anatomical anomaly onTEE or ICE that precludes implantation of the V-LAPIM across the interatrial septum (Fossa Ovalis) including: Septal thickness at fossa > 5 mm, FO Dimension <16mm, ASDor PFO with more than a trace amount of shunting, intra-cardiac thrombus felt to beacute and not present on prior exams and abnormal septum, e.g., a hypermobile septumor a septal aneurysm.

27. Inadequate vascular access for implantation of V-LAPIM or are unable totolerate a right heart catheterization (RHC).

28. Severe pulmonary hypertension at index procedure above 70 mmHg or PVR at indexprocedure above 4.0 Woods Units (mmHg L-1 min-1), while these cannot be loweredwith vasodilators.

29. Resting systolic Blood Pressure <90 or >180 mmHg, not corrected with IV fluidadministration or vasodilators.