search
Back to results

Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study (Trio-ASD)

Primary Purpose

Atrial Septal Defect

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
AMPLATZER™ Septal Occluder.
Occlutech Figulla Flex II®
GORE® CARDIOFORM ASD Occluder
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Septal Defect focused on measuring Transcatheter, Closure, Percutaneous, Atrial Septal Defect

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,
  • 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.

Sites / Locations

  • St. Paul's Hospital
  • Toronto General HospitalRecruiting
  • Institut de Cardiologie de Montreal (MHI)
  • Institut Universitaire de Cardiologie Et Pneumologie de Quebec/Hopital Laval

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Device: ASO

Device: FSO

Device: GSO/GAO

Arm Description

Participants implanted with the AMPLATZER™ Septal Occluder (ASO)

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Subclinical AF (SCAF) burden (days):
Days with >6 min of AF detected on CardioSTAT monitor during 14 days
Subclinical AF (SCAF) burden (number of episodes):
Number of episodes with >6 min of AF detected on CardioSTAT monitor during 14 days
Subclinical AF (SCAF) burden (total time):
Total time in AF during 14 days
Subclinical AF (SCAF) burden (percent time):
Percent time in AF during 14 days
Procedural effectiveness outcomes (acute technical success rate at discharge)
Successful deployment and retention without major device related complications, stroke, myocardial infarction (MI) or arrhythmia requiring antiarrhythmic drug or cardioversion
Procedural effectiveness outcomes (successful closure rate at discharge):
Negative bubble study or residual shunt <2mm
Patient-reported outcomes (QoL):
Quality of life (QoL) using the EuroQoL (EQ-5D-5L™) at baseline, 6 weeks, 24 weeks
Patient-reported outcomes (healthcare utilization):
Healthcare utilization (ED admission, physician visit, etc) at 6 and 24 weeks
Patient-reported outcomes (SF-12):
Quality of life (QoL) using the SF-12 questionnaire at baseline, 6 weeks, 24 weeks
Patient-reported outcomes (HeartQOL):
Quality of life (QoL) using the HeartQOL questionnaire at baseline, 6 weeks, 24 weeks
Patient-reported outcomes (satisfaction with device):
Satisfaction with the use of CardioSTAT and KardiaMobile devices using a Likert scale at 24 weeks

Full Information

First Posted
February 26, 2020
Last Updated
April 5, 2023
Sponsor
University Health Network, Toronto
Collaborators
Montreal Heart Institute, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, St. Paul's Hospital, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT04291898
Brief Title
Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study
Acronym
Trio-ASD
Official Title
Comparative Effectiveness of Three Devices for Transcatheter Closure of Atrial Septal Defects for Adults: A Pilot Study (Trio-ASD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
Collaborators
Montreal Heart Institute, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, St. Paul's Hospital, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Septal Defect
Keywords
Transcatheter, Closure, Percutaneous, Atrial Septal Defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device: ASO
Arm Type
Active Comparator
Arm Description
Participants implanted with the AMPLATZER™ Septal Occluder (ASO)
Arm Title
Device: FSO
Arm Type
Active Comparator
Arm Description
Participants implanted with the Occlutech Figulla Flex II® (FSO).
Arm Title
Device: GSO/GAO
Arm Type
Active Comparator
Arm Description
Participants implanted with the GORE® CARDIOFORM ASD Occluder (GSO/GAO)
Intervention Type
Device
Intervention Name(s)
AMPLATZER™ Septal Occluder.
Intervention Description
Implantation of the AMPLATZER™ Septal Occluder in the ASD.
Intervention Type
Device
Intervention Name(s)
Occlutech Figulla Flex II®
Intervention Description
Implantation of the Occlutech Figulla Flex II® in the ASD.
Intervention Type
Device
Intervention Name(s)
GORE® CARDIOFORM ASD Occluder
Intervention Description
Implantation of the GORE® CARDIOFORM ASD Occluder or GORE® CARDIOFORM Septal Occluder in the ASD.
Primary Outcome Measure Information:
Title
Composite outcome of 'Clinical atrial fibrillation (AF)' or 'Major adverse cerebro-cardiovascular events (MACCE)
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Subclinical AF (SCAF) burden (days):
Description
Days with >6 min of AF detected on CardioSTAT monitor during 14 days
Time Frame
14 days
Title
Subclinical AF (SCAF) burden (number of episodes):
Description
Number of episodes with >6 min of AF detected on CardioSTAT monitor during 14 days
Time Frame
14 days
Title
Subclinical AF (SCAF) burden (total time):
Description
Total time in AF during 14 days
Time Frame
14 days
Title
Subclinical AF (SCAF) burden (percent time):
Description
Percent time in AF during 14 days
Time Frame
14 days
Title
Procedural effectiveness outcomes (acute technical success rate at discharge)
Description
Successful deployment and retention without major device related complications, stroke, myocardial infarction (MI) or arrhythmia requiring antiarrhythmic drug or cardioversion
Time Frame
Discharge, 24 weeks
Title
Procedural effectiveness outcomes (successful closure rate at discharge):
Description
Negative bubble study or residual shunt <2mm
Time Frame
Discharge, 24 weeks
Title
Patient-reported outcomes (QoL):
Description
Quality of life (QoL) using the EuroQoL (EQ-5D-5L™) at baseline, 6 weeks, 24 weeks
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Patient-reported outcomes (healthcare utilization):
Description
Healthcare utilization (ED admission, physician visit, etc) at 6 and 24 weeks
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Patient-reported outcomes (SF-12):
Description
Quality of life (QoL) using the SF-12 questionnaire at baseline, 6 weeks, 24 weeks
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Patient-reported outcomes (HeartQOL):
Description
Quality of life (QoL) using the HeartQOL questionnaire at baseline, 6 weeks, 24 weeks
Time Frame
Baseline, 6 weeks, 24 weeks
Title
Patient-reported outcomes (satisfaction with device):
Description
Satisfaction with the use of CardioSTAT and KardiaMobile devices using a Likert scale at 24 weeks
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lusine Abrahamyan, MD, PhD
Phone
416-340-4800
Email
lusine.abrahamyan@theta.utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Horlick, MD
Phone
416-340-3835
Email
eric.horlick@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Horlick, MD
Organizational Affiliation
University Health Network, Peter Munk Cardiac Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lusine Abrahamyan, MD, PhD
Organizational Affiliation
University Health Network, Theta Collaborative
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Carere, MD
First Name & Middle Initial & Last Name & Degree
Mounir Riahi, MD
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lusine Abrahamyan, MD, PhD
Email
lusine.abrahamyan@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Eric Horlick, MD
First Name & Middle Initial & Last Name & Degree
Lusine Abrahamyan, MD, PhD
Facility Name
Institut de Cardiologie de Montreal (MHI)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reda Ibrahim, MD
First Name & Middle Initial & Last Name & Degree
Anita Asgar, MD
Facility Name
Institut Universitaire de Cardiologie Et Pneumologie de Quebec/Hopital Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep R Cabau, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs