Canadian Adult Congenital Heart Disease Intervention Registry

NCT04288596 | Not Yet Recruiting DMC

• 1 other identifier: CRegistry
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Other: Participants undergoing ACHD intervention

Interventions

Participants undergoing ACHD intervention OTHER

Participants will receive standard of care for their ACHD intervention.

Eligible for Registry

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population includes all consecutive patients who undergo any of the five ACHDi interventions (complex catheterization, ASD closure, PFO closure, CoA stenting, and PPVI) from the time of launching the registry (April 1, 2020 as the tentative starting date), and consent to participate in the registry.

You may qualify if:

• 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.

You may not qualify if:

• participants below the age of 18
• participants residing outside of Canada

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial; Foramen Ovale, Patent; Tetralogy of Fallot; Aortic Coarctation; Transposition of Great Vessels

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Eric Horlick, MD

  University Health Network, Peter Munk Cardiac Centre

  PRINCIPAL INVESTIGATOR

• Lusine Abrahamyan, MD, PhD

  University Health Network, Theta Collaborative

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lusine Abrahamyan, MD, PhD

CONTACT

416-634-8782; lusine.abrahamyan@theta.utoronto.ca

Eric Horlick, MD

CONTACT

eric.horlick@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional and Congenital Cardiologist

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: April 1, 2020
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)