4
• Pulmonary artery systolic pressure greater than half the systemic systolic
arterial pressure unless the indexed pulmonary arteriolar resistance was
<5 Woods units.
• Multiple defects based on screening imaging and stop-flow balloon sizing
that would require placement of more than one device.
Subjects provided informed consent prior to enrollment. No training cases were
required by study investigators prior to enrollment in the Pivotal Study.
Procedure and Follow-up
Dimensional verification and characterization of the ASD, interatrial septum, and
surrounding cardiac structures were performed during the implant procedure. The
measurement of ASD size was taken utilizing the stop-flow technique
(a balloon was placed across the defect and slowly expanded until it filled
the defect space and blood flow through the defect was prevented). The
measurement of the balloon’s waist (i.e. the narrowest portion) was recorded
as the defect diameter and used to determine the appropriate size GORE®
CARDIOFORM Septal Occluder. Fluoroscopic and echocardiographic guidance
were used throughout the procedure for placement and assessment of the GORE®
CARDIOFORM Septal Occluder. All subjects were placed on the investigator’s
choice of antiplatelet therapy for six months following device implantation,
and on prophylactic, post-procedure antibiotic therapy consistent with the
investigator’s routine procedure.
Follow-up evaluations, which included a physical exam, ECG, and an assessment
of residual shunt status by echocardiography, were performed at hospital
discharge, and at 1 and 6 months post-procedure. At the 6-month follow-up visit,
fluoroscopic examination was performed to assess device integrity.
Endpoints
The primary endpoint for the study was Composite Clinical Success, evaluated at
6 months post-procedure. Composite Clinical Success was defined as:
1) Successful deployment and retention of a GORE® CARDIOFORM Septal
Occluder, 2) No Serious Adverse Events during 30-day follow-up, 3) No Device
Events through 6-month follow-up, and 4) Clinical closure success, where
the defect was classified as either completely occluded or having a clinically
insignificant shunt at the 6-month follow-up as determined by echocardiography
core lab evaluation. An event was considered a Serious Adverse Event if it led
to death or serious deterioration in health that resulted in a life threatening
illness or injury or in permanent impairment. Device Events were defined as
any post-procedure embolization, post-procedural device removal, or any other
reintervention to the septal defect.
Secondary endpoints evaluated specific safety and efficacy results in study
subjects. Safety endpoints were defined as the proportion of subjects who
experienced a Serious Adverse Event in the first 30 days or a Device Event
through the 6-month follow-up. Technical Success was defined as successful
deployment and retention of a GORE® CARDIOFORM Septal Occluder. Closure
success endpoints were evaluated for those subjects with Technical Success.
Procedure Success was defined as a residual shunt of ≤ 2 mm at the end of the
implant procedure as measured by the investigational site. Closure Success was
defined as a residual shunt ≤ 2 mm at 6-month follow-up as measured by the
echocardiography core lab.
Results
Demographics and Defect Characteristics
Subject demographics at enrollment and defect characteristics assessed at the
implant procedure by the investigational site are listed in Table 2. Subject medical
history is shown in Table 3.
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