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

NCT04291898 | Unknown DMC

• 2 other identifiers: 21-6095TrioASD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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

Keywords

Transcatheter; Closure; Percutaneous; Atrial Septal Defect

Outcome Measures

Primary Outcomes (1)

• Composite outcome of 'Clinical atrial fibrillation (AF)' or 'Major adverse cerebro-cardiovascular events (MACCE)

  At 24 weeks where clinical (AF) includes AF-related, ECG-documented, ED visit/hospitalization/physician visit, cardioversion, ablation or pacemaker implantation or new antiarrhythmic or AF anticoagulant prescription'; MACCE includes 'new onset heart failure (HF), HF-related ED admission, myocardial infarction, stroke, re-intervention, or death.

  24 weeks

Secondary Outcomes (11)

• Subclinical AF (SCAF) burden (days):

  14 days

• Subclinical AF (SCAF) burden (number of episodes):

  14 days

• Subclinical AF (SCAF) burden (total time):

  14 days

• Subclinical AF (SCAF) burden (percent time):

  14 days

• Procedural effectiveness outcomes (acute technical success rate at discharge)

  Discharge, 24 weeks

Study Arms (3)

Device: ASO

ACTIVE COMPARATOR

Participants implanted with the AMPLATZER™ Septal Occluder (ASO)

Device: AMPLATZER™ Septal Occluder.

Device: FSO

ACTIVE COMPARATOR

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

Device: Occlutech Figulla Flex II®

Device: GSO/GAO

ACTIVE COMPARATOR

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

Device: GORE® CARDIOFORM ASD Occluder

Interventions

AMPLATZER™ Septal Occluder. DEVICE

Implantation of the AMPLATZER™ Septal Occluder in the ASD.

Device: ASO

Occlutech Figulla Flex II® DEVICE

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

Device: FSO

GORE® CARDIOFORM ASD Occluder DEVICE

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

Device: GSO/GAO

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Montreal Heart Institute: collaborator
• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: collaborator
• St. Paul's Hospital, Canada: collaborator

Study Sites (4)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

NOT YET RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Institut de Cardiologie de Montreal (MHI)

Montreal, Quebec, H1T 1C8, Canada

NOT YET RECRUITING

Institut Universitaire de Cardiologie Et Pneumologie de Quebec/Hopital Laval

Québec, Quebec, G1V 4G5, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Eric Horlick, MD

  University Health Network, Peter Munk Cardiac Centre

  PRINCIPAL INVESTIGATOR

• Lusine Abrahamyan, MD, PhD

  University Health Network, Theta Collaborative

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lusine Abrahamyan, MD, PhD

CONTACT

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

Eric Horlick, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and outcome assessors will be blinded to the device they receive. Healthcare providers or site coordinators cannot be blinded due to clear differences between devices.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional and Congenital Cardiologist

Model Details: Patients will be randomly assigned to one of three arms for the duration of the study. The arms include: ASO, FSO, GAO/GSO which indicate the type of intervention they will be receiving.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 2, 2020
• Study Start: November 23, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)