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 at least 6months (diagnosis of HF ≥ 6 months), regardless of ejection fraction.

2. NYHA Class II heart failure (HF) subjects, documented at Baseline Visit regardless ofejection fraction, meeting both inclusion criteria in subsections (2a) and (2b) or NYHAClass III heart failure (HF) subjects, documented at Baseline Visit regardless of ejectionfraction, meeting at least one inclusion criteria in subsections (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 be usedexclusively.
5. Receiving maximally-tolerated medical therapy for heart failure as indicated perACC/AHA or ESC Heart Failure Guidelines (guideline-directed medical therapy or GDMT),in the absence of contraindications and lack of availability. GDMT refers to thoseguideline-directed medical therapies having a Class I indication 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 the Baselinevisit. Drug doses, with the exception of diuretics, should be stable for 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 months priorto the Baseline visit. Drug doses, with the exception of diuretics, should bestable for at least 1 month, where stability is defined as no more than a 100%increase or 50% decrease in dose.
• Patients should also receive Class I recommended cardiac rhythm management devicetherapy. Specifically: if indicated by class I guidelines, cardiacresynchronization therapy (CRT), implanted cardioverter-defibrillator (ICD), or apacemaker should be implanted at least 3 months prior to Baseline Visit. Thesecriteria may be waived if a patient is clinically contraindicated for thesetherapies 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 ESC HeartFailure Guidelines will supersede the above guidelines.

4. Provide informed consent for study participation and be willing and able tocomply with the required tests, treatment instructions, and follow-up visits.

Exclusion Criteria:

• 1. Age less than 22 (<22) or greater than 88 (>88) years old. 2. Subjects who areNYHA class IV and ACC/AHA stage D. 3. Subjects with evidence/history of a majorcardiovascular or neurovascular event, such as an intra-cardiac thrombus orhistory of stroke, transient ischemic attack, systemic or pulmonarythromboembolism, deep vein thrombosis (DVT), within the last 6 months of BaselineVisit.

4. Subjects with a resting systolic blood pressure <90 or >180 mmHg. 5. Leftventricular end-diastolic diameter (LVEDD) > 8cm. 6. Have an atrial septal defector patent foramen ovale with more than trace shunting on color Doppler orintravenous bubble study or surgical or interventional correction of congenitalheart disease involving atrial septum, including placement of a PFO or ASDclosure device, and have a hypermobile septum or a septal aneurysm.
5. Subjects with untreated severe valve lesions, which are indicated for surgicalor percutaneous intervention, active valvular vegetations, atrial myxoma,hypertrophic cardiomyopathy with significant resting or provoked subaorticgradient, acute myocarditis, tamponade, or large pericardial effusion,constrictive pericarditis, infiltrative cardiomyopathy (including cardiacsarcoidosis, amyloidosis, and hemochromatosis), or congenital heart disease, as acause of HF.
6. Uncontrolled tachyarrhythmia or bradycardia (heart rate <45). 9. IntractableHF with resting symptoms despite maximal medical therapy (ACC/AHA HF Stage D),including subjects receiving continuous or intermittent outpatient IV vasoactivemedications (e.g., IV inotropes, IV vasodilators), subjects treated with aventricular assist device (VAD).
7. Intolerant to ACE-I, ARB, or ARNI and beta-blocker medical therapy forsubjects classified as HFrEF (EF ≤40%).
8. 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.
9. Subjects not eligible for emergency open-heart, thoracic or vascular surgery.
10. Women of childbearing age. 14. Subjects with a life expectancy that isshorter than 12 months, or those who have received a cardiac transplant or arelisted for cardiac transplantation and likely to be transplanted within 12 monthsof Baseline Visit.
11. Have coagulopathy or uninterruptible anticoagulation therapy orcontraindication for all the forms of antiplatelet/anticoagulant treatmentsanticipated in the protocol.
12. Known history of life-threatening allergy to contrast dye that cannot beproperly pre-medicated.
13. Have an estimated Glomerular Filtration Rate (GFR) <20 ml/min/1.73 m2 by theMDRD method or on chronic renal dialysis.
14. Hepatic impairment with at least one liver Function Test (transaminases,total bilirubin, or alkaline phosphatase) ≥ 3 times upper limit of normal.
15. Gastrointestinal bleeding in the last 6 months. 20. Have severe chronicpulmonary disease requiring continuous home oxygen, chronic oral steroid therapy,hospitalization for exacerbation during prior 6 months, or has severe obstructivephysiology on PFTs (FEV1/FVC <0.70 and FEV1 < 50% normal), if done.
16. Subjects who have an active infection requiring systemic antibiotics or anelevated white blood count (above the local laboratory reference ranges).
17. Have a history of active drug addiction, active alcohol abuse, or psychiatrichospital admission for psychosis within the prior 2 years.
18. Are currently participating in a clinical study or investigation. 24. Subjectotherwise not appropriate for study as determined by the investigator andsubjects who are unwilling to comply with the study protocol, or subjects with ahistory of non-compliance. The reasons must be documented.
19. Subjects contraindicated for trans-septal puncture, TEE or ICE. Intra Procedural Exclusion Criteria: (Intra Procedural Exclusion Criteria will be determined immediately after intracardiacechocardiography or transesophageal echocardiography determination of left atrialanatomy and just before transseptal puncture) 26. Anatomical anomaly on TEE or ICEthat precludes implantation of the V-LAPIM across the interatrial septum (FossaOvalis) including: Septal thickness at fossa > 5 mm, FO Dimension <16mm, ASD or PFOwith more than a trace amount of shunting, intra-cardiac thrombus felt to be acute andnot present on prior exams and abnormal septum, e.g., a hypermobile septum or a septalaneurysm.
20. Inadequate vascular access for implantation of V-LAPIM or are unable to tolerate aright heart catheterization (RHC).
21. 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 lowered withvasodilators.
22. Resting systolic Blood Pressure <90 or >180 mmHg, not corrected with IV fluidadministration or vasodilators.