Atrial Septal Defect
Conditions
Keywords
Atrial, Septal, Defect
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
Interventions
DEVICEAMPLATZER Septal Occluder
AMPLATZER Septal Occluder
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With Two-year Device-related Hemodynamic Compromise | 24 months | The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise. |
| Co-Primary Effectiveness Endpoint | 24 months | The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met: Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt \< 2mm) without the need for surgical repair |
| Co-Primary Safety Endpoint | 24 months | The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AMPLATZER Septal Occluder The single-arm subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body). | 1,000 |
| Total | 1,000 |
Baseline characteristics
| Characteristic | AMPLATZER Septal Occluder |
|---|---|
| Age, Continuous | 21 years |
| Height | 135.3 centimeters |
| Qp/Qs | 2.1 ratio |
| Sex: Female, Male Female | 649 Participants |
| Sex: Female, Male Male | 351 Participants |
| Weight | 45 kilograms |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 489 / 1,000 |
| serious Total, serious adverse events | 57 / 1,000 |
Outcome results
Primary
Co-Primary Effectiveness Endpoint
The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met: Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt \< 2mm) without the need for surgical repair
Time frame: 24 months
Population: The analysis population for the co-primary effectiveness endpoint was all subjects who either reached their two-year visit or demonstrated closure of the atrial septal defect prior to or at their 2-year visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMPLATZER Septal Occluder | Co-Primary Effectiveness Endpoint | 97.87 percentage of participants |
Primary
Co-Primary Safety Endpoint
The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event
Time frame: 24 months
Population: The analysis population for the co-primary safety endpoint is all subjects who either reached their two-year visit or had a device or delivery system related adverse event prior to their 2-year visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMPLATZER Septal Occluder | Co-Primary Safety Endpoint | 6.34 percentage of participants |
Primary
Percent of Subjects With Two-year Device-related Hemodynamic Compromise
The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Time frame: 24 months
Population: The analysis population for the primary efficacy endpoint was all subjects who either reached their two-year visit or had a device-related hemodynamic compromise event.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMPLATZER Septal Occluder | Percent of Subjects With Two-year Device-related Hemodynamic Compromise | 0.65 percentage of participants |