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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eligible for Registry | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Participants undergoing ACHD intervention | Other | Participants will receive standard of care for their ACHD intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the number of subjects enrolled | This is an observational registry. The primary outcome is the number of subjects enrolled who are undergoing ACHD intervention. | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lusine Abrahamyan, MD, PhD | Contact | 416-634-8782 | lusine.abrahamyan@theta.utoronto.ca | |
| Eric Horlick, MD | Contact | eric.horlick@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Eric Horlick, MD | University Health Network, Peter Munk Cardiac Centre | Principal Investigator |
| Lusine Abrahamyan, MD, PhD | University Health Network, Theta Collaborative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
Patient health card numbers will be collected to be linked with Canadian Healthcare administrative databases.
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| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D054092 | Foramen Ovale, Patent |
| D013771 | Tetralogy of Fallot |
| D001017 | Aortic Coarctation |
| D014188 | Transposition of Great Vessels |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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