Canadian Adult Congenital Heart Disease Intervention Registry

Patent Foramen Ovale Clinical Trial

— C-ACHDiR  

Official title:

The Canadian Registry for Adults With Congenital Heart Disease Interventions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04288596
• Other study ID #: CRegistry
• Status: Not yet recruiting
• Start date: April 1, 2020
• Est. completion date: April 1, 2030

Study information

• Verified date: February 2020
• Source: University Health Network, Toronto
• Contact: Lusine Abrahamyan, MD, PhD
• Phone: 416-634-8782
• Email: lusine.abrahamyan[@]theta.utoronto.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9000
• Est. completion date: April 1, 2030
• Est. primary completion date: April 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Participants undergoing ACHD intervention
Participants will receive standard of care for their ACHD intervention.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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