Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
NCT ID: NCT03523416
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
71 participants
INTERVENTIONAL
2018-07-31
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Edwards Transcatheter Atrial Shunt System
Transcatheter Atrial Shunt System
Transcatheter treatment of symptomatic left heart failure patients
Interventions
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Transcatheter Atrial Shunt System
Transcatheter treatment of symptomatic left heart failure patients
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* 6MWT \< 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
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Locations
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UC San Diego Health
La Jolla, California, United States
University California San Francisco
San Francisco, California, United States
University of Florida Health - Jacksonville
Jacksonville, Florida, United States
St. Vincent Medical Group
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Abbott Northwestern
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Montefiore Medical Center
The Bronx, New York, United States
Atrium Health
Charlotte, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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2018-02
Identifier Type: -
Identifier Source: org_study_id
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