RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-04-01

Study Completion:2030-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05686317

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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.	* 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

Inclusion Criteria

Exclusion 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:
* 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.

* 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

Contacts and Locations

Study Contact

Bridget Hurley

CONTACT

(949) 250-2265

bridget_hurley@edwards.com

Melissa Arteaga

CONTACT

(949) 250-2002

melissa_arteaga@edwards.com

Study Locations (Sites)

University of California Irvine

Irvine, California, 92868

United States

University of California San Diego

La Jolla, California, 92027

United States

Scripps Health

La Jolla, California, 92037

United States

University of Southern California

Los Angeles, California, 90033

United States

University of California San Francisco

San Francisco, California, 94143

United States

Medical Center of the Rockies

Loveland, Colorado, 80538

United States

Northwestern University

Evanston, Illinois, 60208

United States

Kansas University Medical Center

Kansas City, Kansas, 66160

United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Mayo Clinic

Rochester, Minnesota, 55902

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

University of Buffalo

Buffalo, New York, 14203

United States

St. Francis Hospital & Heart Center

Roslyn, New York, 11576

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104

United States

Oregon Health and Science University

Oregon City, Oregon, 97239

United States

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096

United States

Medical University of South Carolina Charleston

Charleston, South Carolina, 29425'

United States

Benaroya Virginia Mason

Seattle, Washington, 98101

United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01

Study Completion Date2030-07-31

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2030-07-31

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure