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National Congenital Heart Disease Audit

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ClinicalTrials.gov Identifier: NCT02303535
Recruitment Status : Unknown
Verified October 2016 by University College, London.
Recruitment status was:  Recruiting
First Posted : December 1, 2014
Last Update Posted : November 4, 2016
Sponsor:
Collaborators:
Society for Cardiothoracic Surgery in Great Britain & Ireland
British Congenital Cardiac Association
Information provided by (Responsible Party):
University College, London

Brief Summary:

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.

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.

For 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.

The 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.

The current dataset is available from here:

http://www.ucl.ac.uk/nicor/audits/congenital/datasets


Condition or disease Intervention/treatment
Congenital Heart Disease (CHD) Procedure: Cardiac Surgery Procedure: Therapeutic cardiac catheterisations procedures

Detailed Description:

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

Data collection:

Hospitals use Patient Administration Systems and manual data entry by cardiac database managers to submit data to NICOR.

Data are either assimilated locally using third party commercial software and imported as a .csv file, or entered directly onto the NICOR database.

Data quality:

NICOR 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.

An import log highlights missing and invalid data as well as records that failed to import due to data quality or compatibility issues.

In addition, data is validated by on site visits with a NICOR representative.

Data linkage:

Data 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.

Information governance:

NICOR 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.


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Study Type : Observational
Estimated Enrollment : 120000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Congenital Heart Disease Audit
Study Start Date : April 2000
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Congenital

All patients with congential and acquired heart disease treated by cardiac surgery and therapeutic cardiac catheterisations procedures .

For 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.

Procedure: Cardiac Surgery
All patients with congential and acquired heart disease treated by cardiac surgery procedures.
Other Names:
  • 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)

Procedure: Therapeutic cardiac catheterisations procedures
All patients with congential and acquired heart disease treated by therapeutic cardiac catheterisations procedures .
Other Names:
  • 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




Primary Outcome Measures :
  1. 30 day survival rates [ Time Frame: 30 day survival from operation date ]
    The analysis shows the national survival rates at 30 days for each procedure and the national survival rates for individual procedures by age.


Secondary Outcome Measures :
  1. 1 year survival rates [ Time Frame: 1 year survival rates after the date of the procedure ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

Patient, judged by multidisciplinary team meeting as unsuitable for the procedure

Exclusion Criteria:

Patient, judged by multidisciplinary team meeting, as unsuitable for the procedure


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303535


Contacts
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Contact: James CHAL, MHlthMgmnt 0203 549 5621 nicor-ics@ucl.ac.uk

Locations
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United Kingdom
Southampton General Hospital Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Alder Hey Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L12 2AP
Royal Victoria Hospital Belfast Recruiting
Belfast, Northern Ireland, United Kingdom, BT12 6BA
John Radcliffe Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Freeman Hospital Recruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Leeds General Infirmary Recruiting
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Queen Elizabeth Hospital (Edgbaston) Recruiting
Birmingham, United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6NP
The Harley Street Clinic Recruiting
London, United Kingdom, W1G 8BJ
The Heart Hospital Recruiting
London, United Kingdom
Sponsors and Collaborators
University College, London
Society for Cardiothoracic Surgery in Great Britain & Ireland
British Congenital Cardiac Association
Investigators
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Study Chair: Rodney Franklin, MD Royal Brompton & Harefield NHS Foundation Trust

Publications:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02303535     History of Changes
Other Study ID Numbers: NICOR-CONGENITAL
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: October 2016

Keywords provided by University College, London:
Congenital heart disease
European Paediatric Cardiac Code Short List
Specific Procedure Definitions
OPCS
paediatric
pediatric

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities