Canadian Adult Congenital Heart Disease Intervention Registry

Status Not yet recruiting

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.

Clinical Trial 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 Design

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

Clinical Trial Details

NCT number	NCT04288596
Study type	Observational [Patient Registry]
Source	University Health Network, Toronto
Contact	Lusine Abrahamyan, MD, PhD
Phone	416-634-8782
Email	lusine.abrahamyan@theta.utoronto.ca
Status	Not yet recruiting
Phase
Start date	April 1, 2020
Completion date	April 1, 2030

View Details

See also
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Completed	`NCT04604015` - RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt	N/A
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Not yet recruiting	`NCT04549272` - Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
Completed	`NCT02621528` - Lifetech CeraFlex™ Post-Market Surveillance Study	N/A
Terminated	`NCT01018355` - The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI	N/A
Completed	`NCT00831259` - Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)	N/A
Not yet recruiting	`NCT05360771` - Study on the Safety and Effectiveness of the SnowyTM PFO Closure System	N/A
Recruiting	`NCT05546320` - Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale	Phase 4
Recruiting	`NCT05561660` - COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)	Phase 4
Completed	`NCT03904277` - Does Patent Foramen Ovale Size Matter in Men and Women
Recruiting	`NCT06120270` - CeraFlex PFO Closure System PMCF Study
Terminated	`NCT01773252` - Right to Left Cardiac Shunt Detection	Phase 3
Completed	`NCT01216423` - Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale	N/A
Completed	`NCT03377465` - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis	N/A
Active, not recruiting	`NCT04738071` - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Not yet recruiting	`NCT06344494` - Cardiac Interventional ICE Imaging Trial	N/A
Withdrawn	`NCT02378623` - Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Canadian Adult Congenital Heart Disease Intervention Registry — C-ACHDiR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms