ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System

Heart Failure Clinical Trial

— ALT-FLOW II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686317
• Other study ID #: 2022-06
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: October 31, 2029

Study information

• Verified date: August 2023
• Source: Edwards Lifesciences
• Contact: Bridget Hurley
• Phone: (949) 250-2265
• Email: bridget_hurley[@]edwards.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center, randomized, sham-controlled clinical trial.

Description:

The objectives of this trial are to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the treatment of patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (LVEF >40%) who remain symptomatic despite guideline-directed medical therapy (GDMT)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2029
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Symptomatic heart failure
• A primary diagnosis of HFmrEF or HFpEF (LVEF > 40%), and
• NYHA class II to ambulatory NYHA class IV (IVa), and
• Documentation of at least one of the following from the date of initial informed

consent:

• = 1 prior HF hospitalization(s) requiring IV HF therapy in the prior 12 months; AND/OR
• EITHER BNP value > 35 pg/ml or > 125 pg/ml in permanent or long-term persistent atrial fibrillation; OR
• NT-proBNP > 125 pg /ml or > 375 pg /ml in permanent or long-term persistent atrial fibrillation
• 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: o Pulmonary capillary wedge pressure at 20 Watts exercise (PCWP 20W) as measured at end-expiration is elevated to = 25 mmHg and PCWP 20W exceeds right atrial pressure (RAP 20W) 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:
• ACC/AHA/ESC Stage D HF, non-ambulatory NYHA Class IV HF
• If Body Mass Index (BMI) < 30, cardiac index < 2.0 L/min/m2
• If BMI = 30, cardiac index < 1.8 L/min/m2
• Inotropic infusion (continuous or intermittent) within the past 6 months
• Patient is on the cardiac transplant waiting list
• Prior diagnosis of HF with reduced ejection fraction (HFrEF), including patients with improvement in LVEF to > 40%
• Valve disease:
• Degenerative mitral regurgitation > moderate
• Functional or secondary mitral valve regurgitation defined as grade > moderate
• Mitral stenosis > mild
• Primary or secondary tricuspid valve regurgitation defined as grade > moderate
• 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:

• Tricuspid annular plane systolic excursion (TAPSE) <1.4 cm, or
• RV size = LV size
• Right ventricular ejection fraction (RVEF) < 35%; OR
• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Edwards APTURE transcatheter shunt system
Treatment with APTURE shunt

Diagnostic Test:
• Sham procedure
CS angiography

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device + Medical Therapy: Subjects with Early Major Adverse Events	Shunt implant safety: proportion of patients in the APTURE shunt group without any serious device or procedure-related (CEC adjudicated) complications (i.e., Major Adverse Cardiovascular, Cerebrovascular, and Renal Events [MACCRE]; at 30 days post index procedure or hospital discharge, whichever is later.	30 days
Primary	Mean change in PCWP from baseline at 20W exercise	Hemodynamic Effectiveness: change in PCWP at 20W exercise from baseline (mmHg) at 6 months.	6-months
Secondary	KCCQ-OSS change from baseline at 6-month follow-up		6-months
Secondary	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.		6-months
Secondary	6MWT change from baseline at 6-month follow-up		6-months