Transcatheter Exclusion of Atrial-septal-aneurysm (TEA)
Transcatheter Exclusion of Atrial-septal-aneurysm (TEA)
This study aims to investigate the safety and efficacy of transcatheter exclusion of atrial
 septal aneurysm (ASA) via transseptal perforation in patients with ASA.
Atrial septal aneurysm (ASA) has been considered a potential cardiac source of embolism, and
 its prevalence is about 1%. In adult patients with stroke and normal carotid arteries, ASA is
 an important predictor of recurrent stroke. The most common abnormalities associated are
 interatrial shunts, that is, a patent foramen ovale (PFO) or an atrial septal defect (ASD).
 For large ASA with interatrial shunt, it is difficult to cover ASA with conventional devices,
 which might result in unstability of occluders and related complications . For isolated ASA
 with high risk, thrombus and emboli have been reported and anticoagulation has been used
 empirically.

 In addition, the left atrial septal pouch can be considered as a special subtype of atrial
 septal aneurysm, in which thrombus might arise from the cavity of the pouch. Pervious
 researches have noted that left atrial septal pouch was a site of origin of thrombus
 formation and a source of embolism, and it was associated with cryptogenic stroke. For
 patients with ASA, we hypothesizes that transcatheter reconstruction of atrial septum might
 be achieved with PFO occluder through transseptal perforation. The aim of this study is to
 investigate the safety and efficacy of transcatheter exclusion of ASA via transseptal
 perforation.

 This study will enroll subjects with ASA (including left atrial septal pouch), and enrollment
 will be divided into three phases.

 Phase 1: large ASA patients with interatrial communication (ASD or PFO). A maximum of 30
 patients is reached.

 Phase 2: ASA patients with intact septum and high risk of cryptogenic stroke. A maximum of 20
 patients is reached.

 Phase 3: left atrial septal pouch with high risk of cryptogenic stroke. A maximum of 20
 patients is reached.
Inclusion Criteria:

 1. In large-ASA patients with PFO (Phase1) (1)The length of ASA >20 mm and bulging >10 mm
 or a combined total excursion right and left > 15 mm; (2)Presence of a PFO indicated
 for device closure (Echocardiographic and/or transcranial Doppler evidence of right to
 left shunt at the atrial level); (3)History of cryptogenic stroke/TIA/migraine without
 other risks; (4) Failure to cover ASA after trial device-closure of PFO and the
 unstable device confirmed with push-pull test;

 2. In large-ASA patients with secundum ASD (Phase1) (1)The length of ASA >20 mm and
 bulging >15 mm or a combined total excursion right and left > 15 mm; (2)Secundum ASD
 with Qp/Qs>1.5 or echocardiographic evidence of right heart enlargement; (3)Failure to
 cover ASA after trial device-closure of ASD and the unstable device confirmed with
 push-pull test;

 3. Isolated ASA with high risk (Phase2) (1)History of migraine attacks/TIA/cryptogenic
 stroke without other risks in the last 6 months; (2)Thickening of ASA wall ≥ 5 mm;
 (3)Spontaneous echo contrast;

 4. Left atrial septal pouch (Phase3) (1)History of migraine attacks/TIA/cryptogenic
 stroke without other risks in the last 6 months; (2)Spontaneous echo contrast in left
 atrium;

 Exclusion Criteria:

 1. Acute infection or sepsis;

 2. Intra-cardiac thrombus;

 3. Carotid, vertebral or basilar artery stenosis > 50% on duplex imaging;

 4. Patients unable to grant informed, written consent.