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Canadian Adult Congenital Heart Disease Intervention Registry

NCT ID: NCT04288596

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

9000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2030-04-01

Brief Summary

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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.

Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Participants undergoing ACHD intervention

Intervention Type OTHER

Participants will receive standard of care for their ACHD intervention.

Interventions

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Participants undergoing ACHD intervention

Participants will receive standard of care for their ACHD intervention.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Eric Horlick

Interventional and Congenital Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Horlick, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Peter Munk Cardiac Centre

Lusine Abrahamyan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Theta Collaborative

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Lusine Abrahamyan, MD, PhD

Role: CONTACT

Phone: 416-634-8782

Email: [email protected]

Eric Horlick, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Lusine Abrahamyan, MD, PhD

Role: primary

Other Identifiers

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CRegistry

Identifier Type: -

Identifier Source: org_study_id