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

NCT ID: NCT04291898

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2024-10-01

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.

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 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.

Conditions

Atrial Septal Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Device: ASO

Participants implanted with the AMPLATZER™ Septal Occluder (ASO)

Group Type: ACTIVE_COMPARATOR

AMPLATZER™ Septal Occluder.

Intervention Type: DEVICE

Implantation of the AMPLATZER™ Septal Occluder in the ASD.

Device: FSO

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

Group Type: ACTIVE_COMPARATOR

Occlutech Figulla Flex II®

Intervention Type: DEVICE

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

Device: GSO/GAO

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

Group Type: ACTIVE_COMPARATOR

GORE® CARDIOFORM ASD Occluder

Intervention Type: DEVICE

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

Interventions

AMPLATZER™ Septal Occluder.

Implantation of the AMPLATZER™ Septal Occluder in the ASD.

Intervention Type: DEVICE

Occlutech Figulla Flex II®

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

Intervention Type: DEVICE

GORE® CARDIOFORM ASD Occluder

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montreal Heart Institute

OTHER

Sponsor Role: collaborator

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

OTHER

Sponsor Role: collaborator

St. Paul's Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Eric Horlick

Interventional and Congenital Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Horlick, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Peter Munk Cardiac Centre

Lusine Abrahamyan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Theta Collaborative

Locations

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status: NOT_YET_RECRUITING

Toronto General Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Institut de Cardiologie de Montreal (MHI)

Montreal, Quebec, Canada

Site Status: NOT_YET_RECRUITING

Institut Universitaire de Cardiologie Et Pneumologie de Quebec/Hopital Laval

Québec, Quebec, Canada

Site Status: NOT_YET_RECRUITING

Countries

Canada

Central Contacts

Lusine Abrahamyan, MD, PhD

Role: CONTACT

lusine.abrahamyan@theta.utoronto.ca

416-340-4800

Eric Horlick, MD

Role: CONTACT

eric.horlick@uhn.ca

416-340-3835

Facility Contacts

Ronald Carere, MD

Role: primary

Mounir Riahi, MD

Role: backup

Lusine Abrahamyan, MD, PhD

Role: primary

lusine.abrahamyan@utoronto.ca

Reda Ibrahim, MD

Role: primary

Anita Asgar, MD

Role: backup

Josep R Cabau, MD

Role: primary

Other Identifiers

TrioASD

Identifier Type: OTHER

Identifier Source: secondary_id

21-6095

Identifier Type: -

Identifier Source: org_study_id