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Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs (ASSURED)

Primary Purpose

Atrial Septal Defect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GORE® CARDIOFORM ASD Occluder
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Septal Defect

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix Children's Hospital
  • University of California-Los Angeles
  • The Children's Hospital of Colorado
  • Yale University School of Medicine
  • Nicklaus Children's Hospital
  • Children's Healthcare at Egleston
  • Riley Hospital for Children
  • Massachusetts General Hospital
  • Children's Hospital Boston
  • University of Michigan
  • Children's Hospital of Michigan
  • Mayo Clinic - Rochester
  • Mount Sinai Medical Center
  • Columbia University Medical Center/New York Presbyterian Hospital
  • Atrium Health
  • Cincinnati Children's Hospital Medical Center
  • Cleveland Clinic Foundation
  • Nationwide Children's Hospital
  • Children's Hospital of Philadelphia
  • Texas Children's Hospital
  • University of Utah
  • Children's Hospital & Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device

Arm Description

ASD closure with the GORE® CARDIOFORM ASD Occluder

Outcomes

Primary Outcome Measures

Number of Subjects With 6-Month Closure Success
Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.
Number of Subjects With 6-Month Composite Clinical Success
Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder Safety Success: Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) through 30 days post-procedure Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (180 days) post-procedure Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation

Secondary Outcome Measures

Number of Subjects With Technical Success
Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder
Number of Subjects With Procedure Success
Among subjects with attempted study device closure, the number of subjects with technical success and measured residual defect status of occluded, small, or moderate of the target ASD at conclusion of index procedure
Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE
Among subjects with attempted study device closure, the number of subjects experiencing one or more device- or procedure-related serious adverse events (SAEs) within 30 days post-index procedure as adjudicated by the Independent Data Review Board (IDRB)
Measured Residual Target Defect Size
Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.
Number of Subjects With Clinically Significant New Arrhythmia
The number of subjects with any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting > 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.) in subjects without prior history of arrhythmia, as adjudicated by the Independent Data Review Board
Number of Subjects With Wire Frame Fracture
Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation.

Full Information

First Posted
November 28, 2016
Last Updated
June 7, 2023
Sponsor
W.L.Gore & Associates
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1. Study Identification

Unique Protocol Identification Number
NCT02985684
Brief Title
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
Acronym
ASSURED
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
September 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Septal Defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Experimental
Arm Description
ASD closure with the GORE® CARDIOFORM ASD Occluder
Intervention Type
Device
Intervention Name(s)
GORE® CARDIOFORM ASD Occluder
Intervention Description
Percutaneous Atrial Septal Defect Closure
Primary Outcome Measure Information:
Title
Number of Subjects With 6-Month Closure Success
Description
Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.
Time Frame
6 months
Title
Number of Subjects With 6-Month Composite Clinical Success
Description
Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder Safety Success: Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) through 30 days post-procedure Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (180 days) post-procedure Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Subjects With Technical Success
Description
Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder
Time Frame
During procedure; median duration 67 minutes
Title
Number of Subjects With Procedure Success
Description
Among subjects with attempted study device closure, the number of subjects with technical success and measured residual defect status of occluded, small, or moderate of the target ASD at conclusion of index procedure
Time Frame
During procedure; median duration 67 minutes
Title
Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE
Description
Among subjects with attempted study device closure, the number of subjects experiencing one or more device- or procedure-related serious adverse events (SAEs) within 30 days post-index procedure as adjudicated by the Independent Data Review Board (IDRB)
Time Frame
30 days
Title
Measured Residual Target Defect Size
Description
Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.
Time Frame
6 months
Title
Number of Subjects With Clinically Significant New Arrhythmia
Description
The number of subjects with any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting > 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.) in subjects without prior history of arrhythmia, as adjudicated by the Independent Data Review Board
Time Frame
6 months
Title
Number of Subjects With Wire Frame Fracture
Description
Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation.
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All responses must be Yes to be eligible: Patient has an ostium secundum ASD with evidence of left-to-right shunt and right ventricular volume overload. Patient has a defect size 8-35 mm as measured directly by stop-flow balloon sizing. Patient vasculature can accommodate the delivery system and procedural accessories. Patient can accommodate TEE or intracardiac echocardiography (ICE) probe for implant procedure. Patient is judged by the implanting physician to have adequate septal rims to retain the study device. 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). 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: 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. 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. 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. 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. Patient has known intracardiac thrombi. 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. Patient is awaiting a procedure that requires trans-septal left atrial access within 6 months of implant procedure. Patient has a history of stroke resulting in a significant morbidity or disability. Patient is pregnant or lactating at time of screening. Patient has contraindication to antiplatelet and anticoagulant medications. Patient has elevated pulmonary vascular resistance (PVR) which in the opinion of the implanting physician precludes safe defect closure. Patient has multiple defects based on screening imaging and stop-flow balloon sizing that would require placement of more than one device.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Sommer, MD
Organizational Affiliation
Columbia University of New York
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Gillespie, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
University of California-Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
The Children's Hospital of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Children's Healthcare at Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19014
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Children's Hospital & Regional Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs

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