Randomized, sham-controlled clinical trial to evaluate the safety, functionality, and efficacy of the Edwards APTURE Transcatheter Shunt System (“APTURE System”).

Canada, Germany, Switzerland, United States (ICTRP)

Identifiant de l'essai ICTRP
NCT05686317 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
A randomized, sham-controLled, clinical Trial For evaLuation Of the EdWards APTURE transcatheter shunt system (ALT-FLOW II) (BASEC)

Titre académique
A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II) (ICTRP)

Titre public
ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System (ICTRP)

Maladie en cours d'investigation
Heart Failure (ICTRP)

Intervention étudiée
Device: Edwards APTURE transcatheter shunt systemDiagnostic Test: Sham procedure (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)

Critères d'inclusion/exclusion
Key Inclusion Criteria:

Symptomatic heart failure

1. A primary diagnosis of HFmrEF or HFpEF (LVEF > 40%), and

2. NYHA class II to ambulatory NYHA class IV (IVa), and

3. Documentation of at least one of the following from the date of initial informed
consent or date of enrollment:

i. Within the prior 12 months, EITHER:

- HF hospital admission (with HF as the primary or secondary diagnosis)

- Treatment with intravenous (IV) or intensification of oral diuretics for HF

ii. Within the prior 6 months, EITHER:

- BNP value > 35 pg/ml in normal sinus rhythm (NSR) or paroxysmal atrial fibrillation
(AF)

- BNP > 125 pg/ml for permanent or long-term persistent AF

- NT-proBNP > 125 pg/ml in NSR or paroxysmal AF

- NT-proBNP > 375 pg/ml for permanent or long-term persistent AF d. There is objective
evidence of cardiogenic pulmonary congestion based on hemodynamic criteria obtained
by right heart catheterization (RHC) at exercise, and confirmed by hemodynamics core
lab as: As measured at end-expiration, pulmonary capillary wedge pressure (PCWP) at
= 20 Watts exercise (PCWP = 20W) is elevated to = 25 mmHg and exceeds [the
corresponding] right atrial pressure (RAP) by = 8 mmHg In the judgment of the
treating physician and the Central Screening Committee the patient is on GDMT for
HFpEF/HFmrEF for >30 days prior to screening and baseline assessments, that is
expected to be maintained without change for 6 months.

Key Exclusion Criteria:

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

1. ACC/AHA/ESC Stage D HF, non-ambulatory NYHA Class IV HF

2. If Body Mass Index (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. Prior diagnosis of HF with reduced ejection fraction (HFrEF), including
patients with improvement in LVEF to > 40%

- Valve disease:

1. Degenerative mitral regurgitation > moderate

2. Functional or secondary mitral valve regurgitation defined as grade > moderate

3. Mitral stenosis > mild

4. Primary or secondary tricuspid valve regurgitation defined as grade > moderate

5. Aortic valve disease defined as aortic regurgitation grade > moderate or aortic
stenosis > moderate

- More than mild right ventricular (RV) dysfunction as determined by the echo core
lab, taking into account the following available parameters:

1. Tricuspid annular plane systolic excursion (TAPSE) <1.4 cm, or

2. RV size = LV size

3. Right ventricular ejection fraction (RVEF) < 35% or

4. Imaging or clinical evidence of congestive hepatopathy

- Mean right atrial pressure (mRAP) > 15 mmHg at rest

- Pulmonary vascular resistance (PVR) = 5.0 WU

- BMI = 45

- Myocardial infarction (MI) and/or any therapeutic invasive, non-valvular
cardiovascular procedure within past 3 months or current indication for coronary
revascularization

- Stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT) or pulmonary
embolus within the past 6 months

- Renal insufficiency as determined by creatinine (sCr) level > 2.5 mg/dL or estimated
glomerular filtration rate (eGFR) < 25ml/min/1.73 m2 by CKD-Epi equation or
currently requiring dialysis

- Performance of the six-minute walk test (6MWT) with a distance < 50m OR > 450m

- Active endocarditis or infection requiring intravenous antibiotics within 3 months (ICTRP)

non disponible

Critères d'évaluation principaux et secondaires
Device + Medical Therapy: Subjects with Early Major Adverse Events;Mean change in PCWL from baseline at 6 months (ICTRP)

KCCQ-OSS change from baseline at 6-month follow-up;Proportion of individual patient success defined as being free from death, disabling stroke, and HF hospitalization with at least (=) a 15-point improvement from baseline KCCQ-OSS or at least (=) a 25m improvement from baseline 6MWT.;6MWT change from baseline at 6-month follow-up (ICTRP)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
non disponible

Contacts supplémentaires
Bridget Hurley, bridget_hurley@edwards.com, (949) 250-2265 (ICTRP)

ID secondaires
2022-06 (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05686317 (ICTRP)