Clinical trial NCT02985684: Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
Official title: GORE® CARDIOFORM ASD Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs) - The Gore ASSURED Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Septal Defect
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2016-12-07
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)

Detailed description: This is a prospective, multicenter, single-arm clinical study comparing outcomes with the GORE® CARDIOFORM ASD Occluder to performance goals derived from clinical investigation outcomes for devices indicated for ASD closure.

Eligibility criteria: Inclusion Criteria:

All responses must be Yes to be eligible:

1. Patient has an ostium secundum ASD with evidence of left-to-right shunt and right ventricular volume overload.
2. Patient has a defect size 8-35 mm as measured directly by stop-flow balloon sizing.
3. Patient vasculature can accommodate the delivery system and procedural accessories.
4. Patient can accommodate TEE or intracardiac echocardiography (ICE) probe for implant procedure.
5. Patient is judged by the implanting physician to have adequate septal rims to retain the study device.
6. Patient (or legal guardian, if patient is a minor) will voluntarily sign a Patient Informed Consent Form (ICF) specific to the study. The Patient ICF must be reviewed and approved in a manner that complies with requirements of the hospital's Institutional Review Board (IRB).
7. Patient (and legal guardian, if patient is a minor) is physically and mentally willing to comply with all study follow-up requirements through 36 months, including routinely scheduled diagnostic testing and physical examinations.

Exclusion Criteria:

All responses must be No to be eligible:

1. Patient has significant known pre-existing electrophysiologic or structural cardiovascular defect, or other comorbidities that could elevate morbidity or mortality beyond what is common for ASD or would require surgical treatment within three (3) years of device placement. Examples include, but are not limited to, large ventricular septal defect, hypoplastic left heart syndrome, coarctation, univentricular heart or tricuspid atresia, pulmonary hypertension, coronary artery disease, valvular or myocardial dysfunction, and other congenital heart disease requiring surgical repair.
2. Patient has systemic or inherited conditions that would significantly increase risk of major morbidity and mortality during the term of the study. Examples include endocarditis, cancer, degenerative neuromuscular disorder, cardiomyopathy, and any condition expected to result in significant deterioration of health within three (3) years of the index procedure.
3. Patient has anatomy where the size or position of the occluder would interfere with other intracardiac or intravasculature structures, such as cardiac valves or pulmonary veins.
4. Patient has active endocarditis, other infections producing bacteremia, or has known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement.
5. Patient has known intracardiac thrombi.
6. Patient has an uncontrolled arrhythmia with evidence of arrhythmia control failure within the past 90 days (e.g., supraventricular tachycardia while under rate control or atrial fibrillation while under rhythm control) or requires electrophysiology study or concomitant intervention with device placement.
7. Patient is awaiting a procedure that requires trans-septal left atrial access within 6 months of implant procedure.
8. Patient has a history of stroke resulting in a significant morbidity or disability.
9. Patient is pregnant or lactating at time of screening.
10. Patient has contraindication to antiplatelet and anticoagulant medications.
11. Patient has elevated pulmonary vascular resistance (PVR) which in the opinion of the implanting physician precludes safe defect closure.
12. Patient has multiple defects based on screening imaging and stop-flow balloon sizing that would require placement of more than one device.

Primary outcomes:
measure: Number of Subjects With 6-Month Closure Success
timeFrame: 6 months
measure: Number of Subjects With 6-Month Composite Clinical Success
timeFrame: 6 months
Secondary outcomes:
measure: Number of Subjects With Technical Success
timeFrame: During procedure; median duration 67 minutes
measure: Number of Subjects With Procedure Success
timeFrame: During procedure; median duration 67 minutes
measure: Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE
timeFrame: 30 days
measure: Measured Residual Target Defect Size
timeFrame: 6 months
measure: Number of Subjects With Clinically Significant New Arrhythmia
timeFrame: 6 months
measure: Number of Subjects With Wire Frame Fracture
timeFrame: 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: University of California-Los Angeles
state: California
city: Aurora
country: United States
facility: The Children's Hospital of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare at Egleston
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Children's Hospital & Regional Medical Center
state: Washington
Study officials:
affiliation: Columbia University of New York
name: Robert Sommer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Matthew Gillespie, MD
role: PRINCIPAL_INVESTIGATOR
References: