Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation Criteria

Inclusion Criteria:

* ≥18 years old referred for percutaneous (secundum) ASD closure with right atrial and ventricular enlargement; and
* clinically significant left-to-tight shunt (Qp:Qs≥1.5:1), or
* evidence of paradoxical embolism (with a TEE defect \>10mm),
* written informed consent

Exclusion Criteria:

* TEE/CCT/CMR defect diameter \>30mm,
* rim sizes of \< 5 mm to the coronary sinus, inferior vena cava rim, an atrioventricular valve, or the right upper pulmonary vein,
* multiple defects,
* complex congenital heart disease requiring surgical repair within 3 years of device placement,
* Eisenmenger-syndrome,
* recent myocardial infarction PCI/CABG \< 6 weeks,
* demonstrated intra cardiac thrombi on echocardiography (especially LA or LAA thrombi), or atrial tumor
* known occluded bilateral femoral veins/IVC,
* pulmonary artery systolic pressure more than half the systemic systolic arterial pressure
* recent pelvic venous thrombosis
* serious comorbidity with life expectancy \<3 years (e.g., non-skin cancers not in remission, advanced renal failure serum creatinine \>160 umol/L)
* patients whose size or condition would cause the patient to be a poor candidate choice for cardiac catheterization (e.g., too small for echocardiographic imaging probe, catheter size, vascular size, active infection, body weight \< 8 kg)
* serious infection in \< 6 weeks producing bacteremia (e.g. sepsis), active endocarditis, or any other infection that cannot be treated successfully prior to device implantation (patient must have negative blood cultures off antibiotics for 1 week prior to procedure),
* active GI bleed \< 6 weeks,
* bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months
* previous stroke in the past 12 months,
* documented chronic atrial fibrillation or \>2 episodes of documented paroxysmal atrial fibrillation in the last 12 months,
* pregnancy or breastfeeding, plan to become pregnant within the next 6 months, not using an effective method of birth control in premenopausal women,
* documented nickel/titanium allergy, or intolerance to contrast agents.