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

NCT05686317 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2022-06
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 28

Brief Summary

This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

• Mean change in PCWL from baseline at 6 months

  Hemodynamic Effectiveness: change in pulmonary capillary wedge during load (PCWL, mmHg/W/kg) from baseline at 6 months.

  6-months

Secondary Outcomes (3)

• KCCQ-OSS change from baseline at 6-month follow-up

  6-months

• 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

• 6MWT change from baseline at 6-month follow-up

  6-months

Study Arms (2)

APTURE shunt + medical therapy

EXPERIMENTAL

Device: Edwards APTURE transcatheter shunt system

Sham + medical therapy

SHAM COMPARATOR

Diagnostic Test: Sham procedure

Interventions

Sham procedure DIAGNOSTIC_TEST

CS angiography

Sham + medical therapy

Edwards APTURE transcatheter shunt system DEVICE

Treatment with APTURE shunt

APTURE shunt + medical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (28)

University of California Irvine

Irvine, California, 92868, United States

Location

University of California San Diego

La Jolla, California, 92027, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Ascension Illinois Heart and Vascular Medical Group

Elk Grove, Illinois, 60007, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

St. Francis Hospital & Heart Center

Roslyn, New York, 11576, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Oregon Health and Science University

Oregon City, Oregon, 97239, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina Charleston

Charleston, South Carolina, 29425', United States

Location

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

Location

Instituto do Coracao da Universidade de Sao Paulo

São Paulo, 05403-900, Brazil

Location

The Ottawa Hospital

Ottawa, Canada, Canada

Location

St. Michael's Hospital

Toronto, Canada, M5B 1WB, Canada

Location

Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

Location

Herzzentrum Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik für Innere Medizin und Kardiologie

Dresden, 01307, Germany

Location

Universitätsklinikum Heidelberg Medizinische Klinik

Heidelberg, 69120, Germany

Location

Johannes Gutenberg Universitaet Mainz

Mainz, 55131, Germany

Location

Inselspital Bern

Bern, Switzerland, 3010, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): August 31, 2030
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (18); BR (1); DE (5); CA (2); CH (2)