An observational study in Atrial Septal Defect, Patent Foramen Ovale and Tetralogy of Fallot, sponsored by University Health Network, Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by University Health Network, Toronto · Observational
The ACHDi Registry study will create a foundational database for adult congenital heart disease interventions. This Pan-Canadian Registry will collect clinical and patient-reported information that will enable the evaluation of care processes and outcomes in five most common ACHDi interventions by enabling prospective and retrospective registry-based studies to answer important clinical practice and policy-relevant questions.
The goal of this study is to establish a rigorously developed registry to enable an impactful research agenda in adults with congenital heart disease interventions (ACHDi). The clinical and patient-reported information captured in the Registry will allow researchers to evaluate care processes and outcomes in five most common ACHDi interventions including transcatheter closure of atrial septal defects, closure of patent foramen ovale, coarctation of aorta stenting, percutaneous pulmonary valve implantation, and complex catheterization.
In 2019, we established the Canadian Research Network for ACHD Interventions (CRN-ACHDi), a national ACHD research network bringing together researchers, providers, patients, and policymakers from 4 provinces (Alberta, British Columbia, Ontario and Quebec) to improve patient experiences and outcomes through i) a national registry with modern data platform; ii) a rigorously established national research priorities agenda; and iii) a strong collaborative and multidisciplinary research environment.
The C-ACHDi Registry will provide opportunities for researchers to ask clinical practice and policy-relevant research questions that are supported by high quality data. In addition, it will provide an opportunity for patients to contribute data for meaningful and high quality clinical and translational research. The C-ACHDi Registry will provide a base for conducting registry-based studies (e.g., prospective experimental, prospective and retrospective observational) in the future as well as a foundation for benchmark and quality improvement activities.
136 studies on the registry are indexed under Foramen Ovale, Patent; 47 are open to participants now.
This study's planned enrollment of 9,000 is above the median of 254 across 59 observational studies indexed under Foramen Ovale, Patent.
Browse Foramen Ovale, Patent studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Compared within Foramen Ovale, Patent, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Septal Defects, Atrial. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Study population includes all consecutive patients who undergo any of the five ACHDi interventions (complex catheterization, ASD closure, PFO closure, CoA stenting, and PPVI) from the time of launching the registry (April 1, 2020 as the tentative starting date), and consent to participate in the registry.
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Exclusion Criteria:
All consecutive patients who undergo any of the five ACHDi interventions (complex catheterization, ASD closure, PFO closure, CoA stenting, and PPVI) at the time of Registry launch, who have also consented to participate.
Other: Participants undergoing ACHD intervention
Participants will receive standard of care for their ACHD intervention.
the number of subjects enrolled
This is an observational registry. The primary outcome is the number of subjects enrolled who are undergoing ACHD intervention.
Time frame: baseline
Plan to share: Yes — Patient health card numbers will be collected to be linked with Canadian Healthcare administrative databases.
No publications or documents are linked to this record.
Start is estimated for Apr 2020; primary completion for Apr 2030, 120 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto →