Status:
UNKNOWN
Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Montreal Heart Institute
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Conditions:
Atrial Septal Defect
Eligibility:
All Genders
18-110 years
Phase:
NA
Brief Summary
This is a proposal, for the first time in Canada, to examine the comparative effectiveness of three commercially available devices (ASO, FSO, and GAO/GSO) for transcatheter closure of atrial septal de...
Detailed Description
The most widely used transcatheter device for ASD closure is the the Amplatzer Septal Occluder (ASO). Two other devices that entered the Canadian market are the Gore Cardioform ASD occluder (GAO) and ...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
November 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04291898
Start Date
November 23 2022
End Date
October 1 2024
Last Update
April 6 2023
Active Locations (4)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
2
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
3
Institut de Cardiologie de Montreal (MHI)
Montreal, Quebec, Canada, H1T 1C8
4
Institut Universitaire de Cardiologie Et Pneumologie de Quebec/Hopital Laval
Québec, Quebec, Canada, G1V 4G5