Trial Outcomes & Findings for Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs (NCT NCT02985684)
NCT ID: NCT02985684
Last Updated: 2023-06-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
125 participants
Primary outcome timeframe
6 months
Results posted on
2023-06-09
Participant Flow
Participant milestones
| Measure |
Device
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
6-Month Clinical Success Evaluation
STARTED
|
125
|
|
6-Month Clinical Success Evaluation
COMPLETED
|
120
|
|
6-Month Clinical Success Evaluation
NOT COMPLETED
|
5
|
|
6-Month Closure Success Evaluation
STARTED
|
120
|
|
6-Month Closure Success Evaluation
COMPLETED
|
112
|
|
6-Month Closure Success Evaluation
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Device
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
6-Month Clinical Success Evaluation
Missed Echocardiograph
|
5
|
|
6-Month Closure Success Evaluation
Technical Failure (No Device)
|
5
|
|
6-Month Closure Success Evaluation
Device Removal
|
3
|
Baseline Characteristics
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
Baseline characteristics by cohort
| Measure |
Device
n=125 Participants
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Age, Continuous
|
12.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=5 Participants
|
|
Height
|
148 cm
n=5 Participants
|
|
Weight
|
41.5 kg
n=5 Participants
|
|
Hypercholesterolemia
Current
|
8 Participants
n=5 Participants
|
|
Hypercholesterolemia
Previous/Never
|
117 Participants
n=5 Participants
|
|
Hypertension
Current
|
6 Participants
n=5 Participants
|
|
Hypertension
Previous/Never
|
119 Participants
n=5 Participants
|
|
Diabetes Mellitus
Current
|
2 Participants
n=5 Participants
|
|
Diabetes Mellitus
Previous/Never
|
123 Participants
n=5 Participants
|
|
Nicotene Use
Within past year
|
1 Participants
n=5 Participants
|
|
Nicotene Use
>1 year ago
|
2 Participants
n=5 Participants
|
|
Nicotene Use
Never
|
122 Participants
n=5 Participants
|
|
Headaches or Migraines
Current
|
7 Participants
n=5 Participants
|
|
Headaches or Migraines
Previous
|
9 Participants
n=5 Participants
|
|
Headaches or Migraines
Never
|
109 Participants
n=5 Participants
|
|
Cardiac Arrhythmia History
|
17 Participants
n=5 Participants
|
|
Stop Flow Balloon Defect Size
|
17 mm
n=5 Participants
|
|
Multiple Fenestrations
|
18 Participants
n=5 Participants
|
|
Atrial Septal Aneurysm
|
6 Participants
n=5 Participants
|
|
Septal Length
|
39 mm
n=5 Participants
|
|
Anterior-Superior Aortic Rim Length
|
4 mm
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Pivotal subjects with technical success and 6-month clinical residual defect status evaluation
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.
Outcome measures
| Measure |
Device
n=112 Participants
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Number of Subjects With 6-Month Closure Success
|
112 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All enrolled pivotal subjects with 6-month clinical success evaluation
Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components: 1. Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder 2. 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 3. Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation
Outcome measures
| Measure |
Device
n=120 Participants
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Number of Subjects With 6-Month Composite Clinical Success
|
108 Participants
|
SECONDARY outcome
Timeframe: During procedure; median duration 67 minutesPopulation: All pivotal subjects enrolled
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
Outcome measures
| Measure |
Device
n=125 Participants
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Number of Subjects With Technical Success
|
120 Participants
|
SECONDARY outcome
Timeframe: During procedure; median duration 67 minutesPopulation: All pivotal subjects enrolled
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
Outcome measures
| Measure |
Device
n=125 Participants
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Number of Subjects With Procedure Success
|
120 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All enrolled pivotal subjects
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)
Outcome measures
| Measure |
Device
n=125 Participants
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Pivotal subjects with technical success and 6-month measured residual defect status evaluation
Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.
Outcome measures
| Measure |
Device
n=112 Participants
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Measured Residual Target Defect Size
|
0.0 mm
Interval 0.0 to 4.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All pivotal subjects enrolled -- prior history of arrhythmia reported on the medical history form does not preclude assessment for, and finding of, clinically significant new arrhythmia from adjudication by the Independent Data Review Board
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
Outcome measures
| Measure |
Device
n=125 Participants
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Number of Subjects With Clinically Significant New Arrhythmia
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Pivotal subjects with technical success and 6-month fluoroscopy evaluation
Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation.
Outcome measures
| Measure |
Device
n=104 Participants
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Number of Subjects With Wire Frame Fracture
|
37 Participants
|
Adverse Events
Device
Serious events: 8 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Device
n=125 participants at risk
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Cardiac disorders
Supraventricular tachycardia
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
General disorders
Device embolisation
|
1.6%
2/125 • Number of events 2 • 6 months (180 days)
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Nervous system disorders
Migraine with aura
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Product Issues
Thrombosis in device
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Psychiatric disorders
Depression
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Vascular disorders
Deep vein thrombosis
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
Other adverse events
| Measure |
Device
n=125 participants at risk
ASD closure with the GORE® CARDIOFORM ASD Occluder
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure
|
|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
4/125 • Number of events 5 • 6 months (180 days)
|
|
Cardiac disorders
Atrial flutter
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Cardiac disorders
Atrial tachycardia
|
1.6%
2/125 • Number of events 2 • 6 months (180 days)
|
|
Cardiac disorders
Bradycardia
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Cardiac disorders
Palpitations
|
3.2%
4/125 • Number of events 4 • 6 months (180 days)
|
|
Cardiac disorders
Sinus bradycardia
|
1.6%
2/125 • Number of events 2 • 6 months (180 days)
|
|
Cardiac disorders
Sinus tachycardia
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.6%
2/125 • Number of events 2 • 6 months (180 days)
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Gastrointestinal disorders
Enlarged uvula
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Gastrointestinal disorders
Nausea
|
1.6%
2/125 • Number of events 2 • 6 months (180 days)
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
2/125 • Number of events 2 • 6 months (180 days)
|
|
General disorders
Catheter site haematoma
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
General disorders
Fatigue
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
General disorders
Non-cardiac chest pain
|
4.8%
6/125 • Number of events 6 • 6 months (180 days)
|
|
General disorders
Pyrexia
|
1.6%
2/125 • Number of events 2 • 6 months (180 days)
|
|
Hepatobiliary disorders
Jaundice
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Croup infectious
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Nasopharyngitis
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Otitis externa
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Otitis media
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Pharyngitis
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Tooth infection
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Trichomoniasis
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
3/125 • Number of events 3 • 6 months (180 days)
|
|
Infections and infestations
Vaginal infection
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Viral infection
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Injury, poisoning and procedural complications
Contusion
|
2.4%
3/125 • Number of events 3 • 6 months (180 days)
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Investigations
Heart rate decreased
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Metabolism and nutrition disorders
Gout
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Nervous system disorders
Dizziness
|
1.6%
2/125 • Number of events 2 • 6 months (180 days)
|
|
Nervous system disorders
Headache
|
4.8%
6/125 • Number of events 7 • 6 months (180 days)
|
|
Nervous system disorders
Migraine
|
0.80%
1/125 • Number of events 3 • 6 months (180 days)
|
|
Nervous system disorders
Seizure
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Psychiatric disorders
Confusional state
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Renal and urinary disorders
Dysuria
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Renal and urinary disorders
Urinary retention
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Reproductive system and breast disorders
Endometriosis
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
4/125 • Number of events 4 • 6 months (180 days)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal exudate
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
|
Vascular disorders
Haematoma
|
0.80%
1/125 • Number of events 1 • 6 months (180 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place