Exploratory Study of the Edwards Transcatheter Atrial Shunt System (ALt FLOW CANADA)

This is an interventional treatment trial for Heart Failure Read More

Inclusion Criteria:

1. Signed and dated approved informed consent form prior to study related procedures
2. Eighteen years of age or older

3. Chronic symptomatic Heart Failure (HF) documented by the following:

   1. NYHA class II with a history of NYHA class III or greater; NYHA class III, OR ambulatory NYHA class IV within last 12 months AND
   2. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); OR treatment with intravenous (IV) or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility) within the 12 months prior to study entry
4. In the judgment of the investigator, subject is on stable Guideline Directed Medical Therapy (GDMT) for heart failure and management of potential comorbidities according to current ACCF/AHA Guidelines and that is expected to be maintained without change for 3 months
5. Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine ergometer exercise stress test as measured at end-expiration; AND the LA (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine ergometer exercise stress test as measured at end-expiration
6. Willing to attend study follow-up assessments for up to 3 years

Exclusion Criteria:

1. Severe heart failure defined as one or more of the below:

   1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
   2. If BMI < 30, Cardiac index < 2.0 L/min/m2
   3. If BMI ≥ 30, Cardiac index < 1.8 L/min/m2
   4. Inotropic infusion (continuous or intermittent) within the past 6 months
   5. Patient is on the cardiac transplant waiting list
   6. LVEF < 20%

2. Presence of significant valve disease defined by the site cardiologist as:

   1. Mitral valve regurgitation defined as grade > 3+ MR or > moderate MS
   2. Tricuspid valve regurgitation defined as grade > 2+ TR
   3. Aortic valve disease defined as > 2+ AR or > moderate AS
3. MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current indication for coronary revascularization;
4. Valve replacement or surgical annuloplasty within the past 12 months
5. Cardiac Resynchronization Therapy initiated, stroke or transient ischemic attack (TIA) within the past 6 months
6. Hemodynamic instability within 30 days of scheduled implant procedure
7. Patient requiring surgery under general anesthesia for any reason within 30 days of scheduled implant procedure
8. Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis)
9. Has renal insufficiency as determined by creatinine (S-Cr) level > 220 micrmol/L or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis
10. Significant hepatic impairment defined as 3× upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase

11. Right ventricular dysfunction, defined by the site cardiologist as:

    1. More than mild RV dysfunction as estimated by TTE; OR
    2. TAPSE <1.4 cm; OR
    3. RV size ≥ LV size as estimated by TTE; OR
    4. Echocardiographic or clinical evidence of congestive hepatopathy;
12. Evidence of pulmonary hypertension with PVR >4 Wood units
13. Performance of the 6 minute walk test with a distance <50m OR >400m
14. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue); or has a documented coagulopathy.
15. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
16. Known hypersensitivity to Nickel
17. In the judgment of the investigator, life expectancy <12 months for noncardiovascular reasons
18. In the opinion of the investigator, the subject is not an appropriate candidate for the study
19. Anatomy (including implantable devices) that is not compatible with the Edwards Transcatheter Atrial Shunt System
20. Active endocarditis or infection within 3 months of scheduled implant procedure
21. Currently participating (e.g. undergoing trial specific exams/treatment/ procedures) in an investigational drug or device study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational trials.
22. History of intravenous drug use in the last 12 months
23. Positive serum pregnancy test in female subjects of child-bearing potential or nursing mothers or planning on becoming pregnant during the duration of the trial
24. Patient is under guardianship
25. Known pre-existing shunting, determined to be clinically significant by the investigator