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

Not Applicable

Active, not recruiting

Conditions: Heart Failure

Interventions: Device: APTURE transcatheter shunt

Registration Number: NCT04000607

Lead Sponsor: Edwards Lifesciences

Brief Summary: The Exploratory study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 50

Inclusion Criteria

Signed and dated approved informed consent form prior to study related procedures
Eighteen years of age or older
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
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
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
Willing to attend study follow-up assessments for up to 3 years

Exclusion Criteria

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%
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
MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current indication for coronary revascularization;
Valve replacement or surgical annuloplasty within the past 12 months
Cardiac Resynchronization Therapy initiated, stroke or transient ischemic attack (TIA) within the past 6 months
Hemodynamic instability within 30 days of scheduled implant procedure
Patient requiring surgery under general anesthesia for any reason within 30 days of scheduled implant procedure
Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis)
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
Significant hepatic impairment defined as 3× upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
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;
Evidence of pulmonary hypertension with PVR >4 Wood units
Performance of the 6 minute walk test with a distance <50m OR >400m
Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue); or has a documented coagulopathy.
Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
Known hypersensitivity to Nickel
In the judgment of the investigator, life expectancy <12 months for noncardiovascular reasons
In the opinion of the investigator, the subject is not an appropriate candidate for the study
Anatomy (including implantable devices) that is not compatible with the Edwards Transcatheter Atrial Shunt System
Active endocarditis or infection within 3 months of scheduled implant procedure
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.
History of intravenous drug use in the last 12 months
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
Patient is under guardianship
Known pre-existing shunting, determined to be clinically significant by the investigator

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Edwards APTURE transcatheter shunt system	APTURE transcatheter shunt	-

Primary Outcome Measures

Name	Time	Method
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)	30 Days	Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.

Secondary Outcome Measures

Name	Time	Method
Rate at which device is successfully implanted (Device Success)	Day 0	Device is deployed as intended and the delivery system is successfully removed as intended at the time of the patient's exit from the implant procedure room.
Rate at which device is patent and subject is discharged from hospital without the need for additional intervention for the device (Procedural Success)	10 Days post-op	Device success with evidence of shunt patency and hospital discharge without the need for additional surgical or percutaneous intervention related to the study device including unacceptable Qp/Qs values.
Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success)	30 Days	Procedural success without major adverse cardiac, cerebrovascular, and renal events (MACCRE) and re-intervention for study device related complications at 30 days.
Change in the ratio of systemic blood flow (Qs) to the pulmonary blood flow (Qp), called "Qp/Qs", from Baseline to Follow Up	3 Months, 6 Months	Change in Qp/Qs value from Baseline to Follow Up (3Month, 6Month)
Change in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up	3 Months, 6 Months	Change in PCWP value from Baseline to Follow Up (3Month, 6Month)
Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up	3 Months, 6 Months	Change in PAP and RAP values from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up)
Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up	3 Months, 6 Months	Change in PVR value from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up)
Change in two parameters related to Tricuspid Annular Plane Excursion (TAPSE) from Baseline to Follow Up	3 Months, 6 Months	Change in two parameters from Baseline to Follow Up (3Month, 6Month): 1. "TAPSE", Tricuspid Annular Plane Excursion 2. "TAPSE/sPAP", Tricuspid Annular Plane Excursion (TAPSE) divided by the systolic pulmonary Artery Pressure (sPAP)