Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04288596
Other study ID # CRegistry
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date April 1, 2030

Study information

Verified date February 2020
Source University Health Network, Toronto
Contact Lusine Abrahamyan, MD, PhD
Phone 416-634-8782
Email lusine.abrahamyan@theta.utoronto.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 9000
Est. completion date April 1, 2030
Est. primary completion date April 1, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility 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

Study Design


Intervention

Other:
Participants undergoing ACHD intervention
Participants will receive standard of care for their ACHD intervention.

Locations

Country Name City State
Canada Toronto General Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT06192173 - Patent Foramen Ovale Closure in Migraine
Recruiting NCT04610463 - Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism N/A
Completed NCT02882815 - Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder N/A
Completed NCT04604015 - RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt N/A
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
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 NCT06413147 - Long-term Procedural and Device Related Complications of PFO Closure
Not yet recruiting NCT06344494 - Cardiac Interventional ICE Imaging Trial N/A