Atrial Septal Aneurysm Clinical Trial
Official title:
Transcatheter Exclusion of Atrial Septal Aneurysm Via Transseptal Perforation: First-in-human Use Study
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03147014 -
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
|
N/A | |
| Completed |
NCT00562289 -
Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence
|
Phase 3 |