Clinical trial NCT03523416: Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
Official title: Early Feasibility Study Of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2018-05-14
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: The early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
timeFrame: 30 days
Secondary outcomes:
measure: Rate at which device is successfully implanted (Device Success)
timeFrame: Day 0
measure: Rate at which device is patent and subject is discharged from hospital without the need for additional intervention for the device (Procedural Success)
timeFrame: 10 days post-op
measure: Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success)
timeFrame: 30 days
measure: Change in the ratio of systemic blood flow (Qs) to the pulmonary blood flow (Qp), called "Qp/Qs", from Baseline to Follow Up
timeFrame: 3 months, 6 months
measure: Change in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up
timeFrame: 3 months, 6 months
measure: Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up
timeFrame: 3 months, 6 months
measure: Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up
timeFrame: 3 months, 6 months
measure: Change in two parameters related to Tricuspid Annular Plane Excursion (TAPSE) from Baseline to Follow Up
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Health
state: California
city: San Francisco
country: United States
facility: University California San Francisco
state: California
city: Jacksonville
country: United States
facility: University of Florida Health - Jacksonville
state: Florida
city: Indianapolis
country: United States
facility: St. Vincent Medical Group
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Minneapolis
country: United States
facility: Abbott Northwestern
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
References: