Atrial Septal DefectC-ACHDiRNCT04288596
Canadian Adult Congenital Heart Disease Intervention Registry
An observational study of Atrial Septal Defect and Patent Foramen Ovale, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Atrial Septal Defect, Patent Foramen Ovale, Tetralogy of Fallot
- What is being tested?
- Participants undergoing ACHD intervention
- How many people
- 9,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2020to 1 Apr 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- participants below the age of 18
- participants residing outside of Canada
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eric Horlick, MD contact
Canada1 site
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Lusine Abrahamyan, MD, PhD, lusine.abrahamyan@utoronto.ca
About this study
Official title: The Canadian Registry for Adults With Congenital Heart Disease Interventions
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.
Read the 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
- Being tested
- Participants undergoing ACHD intervention
- Medical subject headings
- Heart Septal Defects, Atrial, Foramen Ovale, Patent, Tetralogy of Fallot, Aortic Coarctation, Transposition of Great Vessels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants undergoing ACHD interventionOther
Participants will receive standard of care for their ACHD intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Participants undergoing ACHD intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of subjects enrolled
This is an observational registry. The primary outcome is the number of subjects enrolled who are undergoing ACHD intervention.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Horlick, University Health Network, Toronto
- Investigators
- Eric Horlick, MD, Principal investigator, University Health Network, Peter Munk Cardiac CentreLusine Abrahamyan, MD, PhD, Principal investigator, University Health Network, Theta Collaborative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288596
- Sponsor's protocol ID
- CRegistry
- Acronym
- C-ACHDiR
- Status last verified
- Feb 2020
- First submitted
- 26 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient health card numbers will be collected to be linked with Canadian Healthcare administrative databases.