Recruiting

ASO, FSO, GAO/GSO

Sponsor:

University Health Network, Toronto

Code:

NCT04291898

Conditions

Atrial Septal Defect

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AMPLATZER™ Septal Occluder.

Occlutech Figulla Flex II®

GORE® CARDIOFORM ASD Occluder

Study Details

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 defects (ASD) in adults using a pilot randomized controlled trial.

Conditions

Atrial Septal Defect

Study ID

NCT04291898

Start date

Nov 23, 2022

Status verified date

Apr, 2023

Completion date

Oct 1, 2024

Anticipated

Primary completion date

Oct 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Device: ASO

Participants implanted with the AMPLATZER™ Septal Occluder (ASO)

active comparator: Device: FSO

Participants implanted with the Occlutech Figulla Flex II® (FSO).

active comparator: Device: GSO/GAO

Participants implanted with the GORE® CARDIOFORM ASD Occluder (GSO/GAO)

Interventions

AMPLATZER™ Septal Occluder.

Implantation of the AMPLATZER™ Septal Occluder in the ASD.

Occlutech Figulla Flex II®

Implantation of the Occlutech Figulla Flex II® in the ASD.

GORE® CARDIOFORM ASD Occluder

Implantation of the GORE® CARDIOFORM ASD Occluder or GORE® CARDIOFORM Septal Occluder in the ASD.

Primary outcome measure

  • Composite outcome of 'Clinical atrial fibrillation (AF)' or 'Major adverse cerebro-cardiovascular events (MACCE) [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Lusine Abrahamyan, MD, PhD

416-340-4800lusine.abrahamyan@theta.utoronto.ca

Eric Horlick, MD

416-340-3835eric.horlick@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Lusine Abrahamyan, MD, PhD

lusine.abrahamyan@utoronto.ca

Principal Investigator:

Eric Horlick, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 6, 2023

Last verified

Apr, 2023

Keywords

  • Transcatheter
  • Closure
  • Percutaneous
  • Atrial Septal Defect

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2023-04-06.