Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02303535
Status:
UNKNOWN
Last Update Posted:
2016-11-04
First Post:
2014-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Congenital Heart Disease Audit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D058327', 'term': 'Norwood Procedures'}, {'id': 'D016027', 'term': 'Heart Transplantation'}, {'id': 'D018729', 'term': 'Fontan Procedure'}, {'id': 'D000069278', 'term': 'Arterial Switch Operation'}, {'id': 'D014945', 'term': 'Wound Healing'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D057785', 'term': 'Catheters'}, {'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D017147', 'term': 'Defibrillators, Implantable'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D018610', 'term': 'Heart Bypass, Right'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D012038', 'term': 'Regeneration'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D047548', 'term': 'Defibrillators'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2014-11-25', 'studyFirstSubmitQcDate': '2014-11-25', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30 day survival rates', 'timeFrame': '30 day survival from operation date', 'description': 'The analysis shows the national survival rates at 30 days for each procedure and the national survival rates for individual procedures by age.'}], 'secondaryOutcomes': [{'measure': '1 year survival rates', 'timeFrame': '1 year survival rates after the date of the procedure', 'description': 'Analysis include 1-year outcome but a death would not appear in the table until a full year has passed for the whole cohort of patients within that year. For example, the audit collection period is based on financial year of April 1st to March 31st. A patient that died in April would be reported within the same period as one that died 11 months later in March.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Congenital heart disease', 'European Paediatric Cardiac Code Short List', 'Specific Procedure Definitions', 'OPCS', 'paediatric', 'pediatric'], 'conditions': ['Congenital Heart Disease (CHD)']}, 'referencesModule': {'references': [{'pmid': '23564473', 'type': 'BACKGROUND', 'citation': 'Pagel C, Utley M, Crowe S, Witter T, Anderson D, Samson R, McLean A, Banks V, Tsang V, Brown K. Real time monitoring of risk-adjusted paediatric cardiac surgery outcomes using variable life-adjusted display: implementation in three UK centres. Heart. 2013 Oct;99(19):1445-50. doi: 10.1136/heartjnl-2013-303671. Epub 2013 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and produces analysis to enable hospitals and healthcare improvement bodies to monitor and improve the quality of care and outcomes of cardiovascular patients.\n\nThe Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease.\n\nFor acquired heart disease, the audit covers all arrhythmias \\& cardiomyopathies in patients less than 16 years old only. For congenital heart disease, the audit collects data on both children and adult patients. The audit covers all specialist centers in the UK and Republic of Ireland.\n\nThe project aims to improve the quality of care for children and adults with congenital heart disease by providing national comparative analysis of procedure specific activity and outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit also provides quality indicators for the antenatal detection of major congenital heart disease.\n\nThe current dataset is available from here:\n\nhttp://www.ucl.ac.uk/nicor/audits/congenital/datasets', 'detailedDescription': 'The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease\n\nData collection:\n\nHospitals use Patient Administration Systems and manual data entry by cardiac database managers to submit data to NICOR.\n\nData are either assimilated locally using third party commercial software and imported as a .csv file, or entered directly onto the NICOR database.\n\nData quality:\n\nNICOR provide tools that communicate possible errors to centres submitting data. A data submitting schedule has been agreed with the centres, data is submitted and a validation report is returned each quarter. Centres are responsible for updating errors in the records.\n\nAn import log highlights missing and invalid data as well as records that failed to import due to data quality or compatibility issues.\n\nIn addition, data is validated by on site visits with a NICOR representative.\n\nData linkage:\n\nData is annually linked with Office fot National Statistics (ONS) life status and Hospital Episodes Statistics (HES) admission data to verify case ascertainment and to track long term outcome measures.\n\nInformation governance:\n\nNICOR has Section 251 approval and data protection registration. An organisation-wide standard operating procedure is in place for Information Security Incident Management. University College London has a robust information governance framework, to which NICOR adheres.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All potential patients are assessed through a systematic process of clinical evaluation, diagnostic assessment. Patient selection is effected in each individual unit through a multidisciplinary team process. These teams consist not only of cardiac surgeons and interventional cardiologists but also of many other medical specialties and allied professionals. The decision as to the access route to be used is determined by the multidisciplinary team.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient, judged by multidisciplinary team meeting as unsuitable for the procedure\n\nExclusion Criteria:\n\nPatient, judged by multidisciplinary team meeting, as unsuitable for the procedure'}, 'identificationModule': {'nctId': 'NCT02303535', 'briefTitle': 'National Congenital Heart Disease Audit', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'National Congenital Heart Disease Audit', 'orgStudyIdInfo': {'id': 'NICOR-CONGENITAL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Congenital', 'description': 'All patients with congential and acquired heart disease treated by cardiac surgery and therapeutic cardiac catheterisations procedures .\n\nFor acquired heart disease, the audit covers all arrhythmias \\& cardiomyopathies in patients less than 16 years old only.\n\nFor congenital heart disease, the audit collects data on both children and adult patients.', 'interventionNames': ['Procedure: Cardiac Surgery', 'Procedure: Therapeutic cardiac catheterisations procedures']}], 'interventions': [{'name': 'Cardiac Surgery', 'type': 'PROCEDURE', 'otherNames': ['Norwood procedure (Stage 1)', 'Heart Transplant', 'TAPVD Repair + Arterial Shunt', 'Fontan procedure', 'Bidirectional cavopulmonary shunt', 'Senning or Mustard procedure', 'Truncus and interruption repair', 'Truncus arteriosus repair', 'Tricuspid valve replacement', 'Interrupted aortic arch repair', 'Multiple VSD Closure', 'Mitral valve replacement', 'Repair of total anomalous pulmonary venous drainage', 'Atrioventricular septal defect and tetralogy repair', 'Atrioventricular septal defect (complete) repair', 'Atrioventricular septal defect (partial) repair', 'Aortic valvotomy', 'Aortic valvoplasty', 'Anomalous coronary artery repair', 'Cor triatriatum repair', 'Arterial switch + VSD closure', 'Arterial switch (for isolated transposition)', 'Pulmonary atresia VSD repair', 'Pulmonary valve replacement', 'Tetralogy with absent pulmonary valve repair', 'Tetralogy repair', 'Isolated coarctation repair', 'Aortic Valve Replacement - non Ross', 'Supravalvar aortic stenosis repair', 'Rastelli procedure', 'Aortic valve replacement - Ross', 'Aortic root replacement (not Ross)', 'Subvalvar aortic stenosis repair', 'Aortopulmonary window repair', 'ASD repair', 'VSD Repair', 'Arterial shunt', 'Isolated Pulmonary artery band', 'PDA ligation (surgical)'], 'description': 'All patients with congential and acquired heart disease treated by cardiac surgery procedures.', 'armGroupLabels': ['Congenital']}, {'name': 'Therapeutic cardiac catheterisations procedures', 'type': 'PROCEDURE', 'otherNames': ['Transcatheter PVR', 'VSD closure (catheter)', 'Aortic balloon valvotomy', 'Coarctation angioplasty', 'Pulmonary artery stenting', 'ASD closure (catheter)', 'PDA closure (catheter)', 'Recoarctation angioplasty', 'Pulmonary balloon valvoplasty', 'Blade atrial septostomy', 'Coarctation stenting', 'PFO closure (catheter)', 'Pulmonary valvotomy (radiofrequency)', 'Duct Stenting', 'RVOT Stenting', 'Radiofrequency ablation for supraventricular tachycardia', 'Implantable Cardioverter Defibrillator'], 'description': 'All patients with congential and acquired heart disease treated by therapeutic cardiac catheterisations procedures .', 'armGroupLabels': ['Congenital']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SW3 6NP', 'city': 'London', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1G 8BJ', 'city': 'London', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'The Harley Street Clinic', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'L12 2AP', 'city': 'Liverpool', 'state': 'Merseyside', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Alder Hey Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'BT12 6BA', 'city': 'Belfast', 'state': 'Northern Ireland', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Victoria Hospital Belfast', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'state': 'West Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Leeds General Infirmary', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital (Edgbaston)', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'The Heart Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'James CHAL, MHlthMgmnt', 'role': 'CONTACT', 'email': 'nicor-ics@ucl.ac.uk', 'phone': '0203 549 5621'}], 'overallOfficials': [{'name': 'Rodney Franklin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Royal Brompton & Harefield NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society for Cardiothoracic Surgery in Great Britain & Ireland', 'class': 'UNKNOWN'}, {'name': 'British Congenital Cardiac Association', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}