Canadian Adult Congenital Heart Disease Intervention Registry

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Brief Title

Canadian Adult Congenital Heart Disease Intervention Registry

Official Title

The Canadian Registry for Adults With Congenital Heart Disease Interventions

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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

the number of subjects enrolled


Condition

Atrial Septal Defect

Intervention

Participants undergoing ACHD intervention

Study Arms / Comparison Groups

 Eligible for Registry
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

9000

Start Date

April 1, 2020

Completion Date

April 1, 2030

Primary Completion Date

April 1, 2030

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
      

Gender

All

Ages

18 Years - 110 Years

Accepts Healthy Volunteers

No

Contacts

Eric Horlick, MD, 416-634-8782, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04288596

Organization ID

CRegistry


Responsible Party

Principal Investigator

Study Sponsor

University Health Network, Toronto


Study Sponsor

Eric Horlick, MD, Principal Investigator, University Health Network, Peter Munk Cardiac Centre


Verification Date

February 2020