Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study
Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study
This is a proposal, for the first time in Canada, to examine the comparative effectiveness of
 three commercially available atrial septal defect (ASD) devices in an internal pilot
 randomized trial.
The most widely used transcatheter device for ASD closure is the the Amplatzer Septal
 Occluder (ASO). Two new devices that entered the Canadian market are the Gore Cardioform ASD
 occluder (GAO) and the Figulla Flexible II Occlutech (FSO) device. There exists a paucity of
 data on the comparative efficacy and safety of these devices. This is a proposal, for the
 first time in Canada, to examine the comparative effectiveness of three commercially
 available ASD devices in an internal pilot randomized trial.

 Approximately 60 patients referred for transcatheter ASD closure will be recruited in this
 study over a period of 15 months from 4 participating centers across Canada. This will be a
 registry-based randomized controlled trial (RRCT) where patients will be enrolled into one of
 three arms (ASO, FSO, and GAO/GSO) to compare the effectiveness and safety outcomes of three
 different ASD closure devices.
Inclusion Criteria:

 -  ≥18 years old referred for percutaneous (secundum) ASD closure with right atrial and
 ventricular enlargement; and/or

 -  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 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 < 6 weeks,

 -  demonstrated intra cardiac thrombi on echocardiography (especially LA or LAA thrombi),

 -  unable to have TEE,

 -  occluded bilateral femoral veins/IVC,

 -  serious comorbidity with life expectancy <3 years (e.g., non-skin cancers not in
 remission, advanced renal failure serum creat >160 [Symbol]mol/l),

 -  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,

 -  serious bleeding disorder,

 -  previous stroke,

 -  documented chronic atrial fibrillation or >2 episodes of documented paroxysmal atrial
 fibrillation in the last 12 months,

 -  pregnancy or breastfeeding, plan to become pregnant before the end of the study
 period, not using an effective method of birth control in premenopausal women,

 -  documented nickel allergy,

 -  out of province residents.