Trial Outcomes & Findings for GORE® CARDIOFORM Septal Occluder Migraine Clinical Study (NCT NCT04100135)
NCT ID: NCT04100135
Last Updated: 2026-06-09
Results Overview
Mean reduction in the number of migraine headache days per month from baseline to follow-up
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Week 40
Results posted on
2026-06-09
Participant Flow
Seven (7) screened subjects were eligible and enrolled into the study. These participants then underwent further screening for responsiveness to study medication.
Enrolled subjects found to be responsive to study medication were then randomized to actual study device closure (test) or to sham closure (control). The decision to terminate the trial was made after 2 subjects had been randomized to closure.
Participant milestones
| Measure |
Test Arm
Device PFO closure with the GORE® CARDIOFORM Septal Occluder
|
Control Arm
Sham device PFO closure (catheterization but PFO not closed)
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
Baseline characteristics by cohort
| Measure |
Control Arm
n=1 Participants
Sham device PFO closure (catheterization but PFO not closed)
|
Total
n=2 Participants
Total of all reporting groups
|
Test Arm
n=1 Participants
Device PFO closure with the GORE® CARDIOFORM Septal Occluder
|
|---|---|---|---|
|
Age, Continuous
|
39.9 Years
n=20 Participants
|
45.7 Years
n=40 Participants
|
51.4 Years
n=20 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
|
Migraine headache (MHA) days per month
|
12.0 Days per month
n=20 Participants
|
25.0 Days per month
n=40 Participants
|
13.0 Days per month
n=20 Participants
|
PRIMARY outcome
Timeframe: Week 40Population: No subjects evaluable for this outcome.
Mean reduction in the number of migraine headache days per month from baseline to follow-up
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 30 days post-procedureProportion of subjects with any Serious Adverse Event (SAE) related to the study device or study procedure through 30 days post-procedure
Outcome measures
| Measure |
Test Arm
n=1 Participants
Device PFO closure with the GORE® CARDIOFORM Septal Occluder
|
Control Arm
n=1 Participants
Sham device PFO closure (catheterization but PFO not closed)
|
|---|---|---|
|
Serious Adverse Events (Safety)
|
0 Participants
|
0 Participants
|
Adverse Events
Test Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Arm
n=1 participants at risk
Device PFO closure with the GORE® CARDIOFORM Septal Occluder
|
Control Arm
n=1 participants at risk
Sham device PFO closure (catheterization but PFO not closed)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
100.0%
1/1 • From enrollment until premature study termination, resulting in approximately 1 year of AE follow up for the 2 subjects randomized to closure
|
0.00%
0/1 • From enrollment until premature study termination, resulting in approximately 1 year of AE follow up for the 2 subjects randomized to closure
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1 • From enrollment until premature study termination, resulting in approximately 1 year of AE follow up for the 2 subjects randomized to closure
|
100.0%
1/1 • From enrollment until premature study termination, resulting in approximately 1 year of AE follow up for the 2 subjects randomized to closure
|
|
Infections and infestations
Ear infection
|
0.00%
0/1 • From enrollment until premature study termination, resulting in approximately 1 year of AE follow up for the 2 subjects randomized to closure
|
100.0%
1/1 • Number of events 2 • From enrollment until premature study termination, resulting in approximately 1 year of AE follow up for the 2 subjects randomized to closure
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • From enrollment until premature study termination, resulting in approximately 1 year of AE follow up for the 2 subjects randomized to closure
|
100.0%
1/1 • Number of events 2 • From enrollment until premature study termination, resulting in approximately 1 year of AE follow up for the 2 subjects randomized to closure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place