Clinical trial NCT00650936: Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Official title: Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Septal Defect
Keywords: Atrial
Septal
Defect
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
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 prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder


Eligibility criteria: Inclusion Criteria:

* Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she:

  * is indicated for implantation with the AMPLATZER Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure),
  * is willing and able to complete the follow-up requirements of this study, and
  * signs the informed consent (or a legal representative signs the informed consent).

Primary outcomes:
measure: Percent of Subjects With Two-year Device-related Hemodynamic Compromise
timeFrame: 24 months
measure: Co-Primary Effectiveness Endpoint
timeFrame: 24 months
measure: Co-Primary Safety Endpoint
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Madera
country: United States
facility: Children's Hospital of Central California
state: California
city: Oakland
country: United States
facility: Children's Hospital Oakland
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Pediatric Cardiovascular Center
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Hope Children's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans
state: Louisiana
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: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New Hyde Park
country: United States
facility: Schneider Children's Hospital
state: New York
city: New York
country: United States
facility: The New York Presbyterian Hospital - Cornell Campus
state: New York
city: New York
country: United States
facility: Children's Hospital of New York-Presbyterian
state: New York
city: Rochester
country: United States
facility: Children's Hospital at Strong
state: New York
city: Charlotte
country: United States
facility: Sanger Heart & Vascular Institute/Carolinas Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Children's Hospital at Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: The Children's Hospital
state: Oklahoma
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Moffitt Heart and Vascular Group
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: LeBonheur Children's Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University-Children's
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Austin
country: United States
facility: North Austin Medical Center
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Charlottesville
country: United States
facility: Universtiy of Virginia
state: Virginia
city: Falls Church
country: United States
facility: INOVA Fairfax Hospital
state: Virginia
city: Spokane
country: United States
facility: Sacred Heart Children's Hospital
state: Washington
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
References:
citation: Turner DR, Owada CY, Sang CJ Jr, Khan M, Lim DS. Closure of Secundum Atrial Septal Defects With the AMPLATZER Septal Occluder: A Prospective, Multicenter, Post-Approval Study. Circ Cardiovasc Interv. 2017 Aug;10(8):e004212. doi: 10.1161/CIRCINTERVENTIONS.116.004212.