NCT04288596

Canadian Adult Congenital Heart Disease Intervention Registry

The Canadian Registry for Adults With Congenital Heart Disease Interventions

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 9,000 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Participants undergoing ACHD intervention	Participants will receive standard of care for their ACHD intervention.

Timeline

• Start date: 2020-04-01
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2020-02-28
• Last updated: 2020-02-28

Locations

1 site across 1 country: Canada