Canadian Adult Congenital Heart Disease Intervention Registry

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
The Canadian Registry for Adults With Congenital Heart Disease Interventions

Conditions
-----------------
Tetralogy of Fallot, Atrial Septal Defect, Patent Foramen Ovale, Fontan, Coarctation of Aorta, Transposition of Great Vessels, Percutaneous Pulmonary Valve Implantation

Intervention / Treatment
-----------------
* Other: Participants undergoing ACHD intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants must be 18 years or older referred for intervention for one of five ACHD conditions including diagnostic catheterization for complex ACHD patients (Tetralogy of Fallot, Fontan, and transposition of the great vessels, single ventricle, truncus arteriosus); transcatheter closure of atrial septal defects; transcatheter closure of patent foramen ovale; coarctation of aorta stenting, and percutaneous pulmonary valve implantation. Exclusion Criteria: participants below the age of 18 participants residing outside of Canada

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eligible for Registry<br>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<br>* Participants will receive standard of care for their ACHD intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |