Clinical trial NCT04000607: Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)
Official title: Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2019-06-27
Enrollment: 45
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 Exploratory study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.


Eligibility criteria: Inclusion Criteria:

* Symptomatic HF:

  * NYHA II w/ history of \> II; III; or ambulatory IV AND
  * ≥1 HF hospitalization OR treatment with IV or oral diuresis within 12 months OR Elevated NT-proBNP 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 GDMT for HF
* Left Ventricular Ejection Fraction (LVEF) ≤ 40% as determined by site cardiologist
* Hemodynamic criteria

  o At rest: Elevated LAP (or PCWP) \> 15 mmHg AND LAP \> RAP + 5 mmHg AND/OR supine ergometer exercise: elevated LAP (or PCWP) \> 25 mmHg AND LAP \> RAP + 10 mmHg
* Pulmonary Vascular Resistance (PVR) \< 5.0 WU as determined by site cardiologist

Exclusion Criteria

* Severe HF:

  * NYHA IV, stage D, non-ambulatory, transplant list
  * Cardiac index ≤ 1.5 L/min/m2
  * Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm
  * LVEF \<20%
* Valve disease

  * MR \>3+ or \> moderate MS, TR \>3+ (severe on 5-point scale), 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 \> 220 micromol/L OR e-GFR \< 25ml/min/1.73 m2)
* 6MWT \<50m OR \>400m
* Active endocarditis or infection \< 3 months
* Mean Right Atrial Pressure (mRAP) \> 15 mmHg as determined by site cardiologist
* 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: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References: