Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

NCT03523416 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2018-02
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)

  Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.

  30 days

Secondary Outcomes (8)

• Rate at which device is successfully implanted (Device Success)

  Day 0

• 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

• Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success)

  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 pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up

  3 months, 6 months

Study Arms (1)

Edwards Transcatheter Atrial Shunt System

EXPERIMENTAL

Device: Transcatheter Atrial Shunt System

Interventions

Transcatheter Atrial Shunt System DEVICE

Transcatheter treatment of symptomatic left heart failure patients

Edwards Transcatheter Atrial Shunt System

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 (HF):
• NYHA class II with a history of \> II; III; or ambulatory IV AND
• ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; OR an NT-pro BNP value \> 150 pg./ml in normal sinus rhythm, \> 450 pg./ml in atrial fibrillation, or a BNP value \> 50 pg./ml in normal sinus rhythm, \> 150 pg./ml in atrial fibrillation within the past 6 months prior to study entry.
• On stable Guideline Directed Medical Therapy (GDMT) for heart failure
• At rest: elevated LAP (or PCWP) of \> 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by \> 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of \> 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by \> 10 mmHg
• Left Ventricular Ejection Fraction (LVEF) ≤ 40%
• Pulmonary Vascular Resistance (PVR) \< 4.0 WU

You may not qualify if:

• Severe HF:
• Stage D, non-ambulatory NYHA Class IV, transplant list
• If BMI \< 30, Cardiac index \< 2.0 L/min/m2
• If BMI ≥ 30, cardiac index \< 1.8 L/min/m2
• Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm
• LVEF \< 20%
• Valve disease: MR \> 3+ or \> moderate MS, TR \> 2+, AR \> 2+ or \> moderate AS
• MI or therapeutic invasive cardiac procedure \< 3 months
• TIA, stroke, CRT implanted \< 6 months
• RV dysfunction \> mild by TTE OR TAPSE \< 1.2 OR RV size ≥ LV size by TTE, OR right ventricular fractional area change (RVFAC) ≤ 25%
• Dialysis OR renal dysfunction (S-CR \> 2.5 mg/dl OR eGFR \< 25 ml/min/1.73m2)
• MWT \< 50m OR \> 600m
• Active endocarditis or infection \< 3 months
• Mean Right Atrial Pressure (mRAP) \> 15 mmHg at rest
• Body Mass Index (BMI) ≥ 45 kg/m2

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (15)

UC San Diego Health

La Jolla, California, 92037, United States

Location

University California San Francisco

San Francisco, California, 94143, United States

Location

University of Florida Health - Jacksonville

Jacksonville, Florida, 32209, United States

Location

St. Vincent Medical Group

Indianapolis, Indiana, 46260, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Abbott Northwestern

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• Fioretti F, Hibbert B, Eckman PM, Simard T, Labinaz M, Nazer B, Wiley M, Gupta B, Sauer AJ, Shah H, Sorajja P, Pineda AM, Missov E, Aldaia L, Koulogiannis K, Gray WA, Zahr F, Butler J. Left Atrial-to-Coronary Sinus Shunting in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: The ALT-FLOW Trial (Early Feasibility Study) 2-Year Results. JACC Heart Fail. 2025 Jun;13(6):987-999. doi: 10.1016/j.jchf.2025.02.003. Epub 2025 Feb 11.

  PMID: 40019407 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 14, 2018
• Study Start: July 31, 2018
• Primary Completion: December 15, 2023
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (15)