National Congenital Heart Disease Audit

NCT02303535 | Unknown DMC

• 1 other identifier: NICOR-CONGENITAL
• Study Type: observational
• Target: 120,000
• Locations: 1 country
• Sites: 10

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

Conditions

Congenital Heart Disease (CHD)

Keywords

Congenital heart disease; European Paediatric Cardiac Code Short List; Specific Procedure Definitions; OPCS; paediatric; pediatric

Outcome Measures

Primary Outcomes (1)

• 30 day survival rates

  The analysis shows the national survival rates at 30 days for each procedure and the national survival rates for individual procedures by age.

  30 day survival from operation date

Secondary Outcomes (1)

• 1 year survival rates

  1 year survival rates after the date of the procedure

Study Arms (1)

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; Procedure: Therapeutic cardiac catheterisations procedures

Interventions

Cardiac Surgery PROCEDURE

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

Also known as: 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)

Congenital

Therapeutic cardiac catheterisations procedures PROCEDURE

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

Also known as: 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

Congenital

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• Society for Cardiothoracic Surgery in Great Britain & Ireland: collaborator
• British Congenital Cardiac Association: collaborator

Study Sites (10)

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Royal Brompton Hospital

London, London, SW3 6NP, United Kingdom

RECRUITING

The Harley Street Clinic

London, London, W1G 8BJ, United Kingdom

RECRUITING

Alder Hey Hospital

Liverpool, Merseyside, L12 2AP, United Kingdom

RECRUITING

Royal Victoria Hospital Belfast

Belfast, Northern Ireland, BT12 6BA, United Kingdom

RECRUITING

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

RECRUITING

Leeds General Infirmary

Leeds, West Yorkshire, LS1 3EX, United Kingdom

RECRUITING

Queen Elizabeth Hospital (Edgbaston)

Birmingham, United Kingdom

RECRUITING

The Heart Hospital

London, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 23564473 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Cardiac Surgical Procedures; Norwood Procedures; Heart Transplantation; Fontan Procedure; Arterial Switch Operation; Wound Healing; Surgical Procedures, Operative; Catheters; Radiofrequency Ablation; Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Thoracic Surgical Procedures; Organ Transplantation; Transplantation; Heart Bypass, Right; Anastomosis, Surgical; Vascular Grafting; Vascular Surgical Procedures; Regeneration; Biological Phenomena; Equipment and Supplies; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Defibrillators; Electrodes; Electrical Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Rodney Franklin, MD

  Royal Brompton & Harefield NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

James CHAL, MHlthMgmnt

CONTACT

0203 549 5621; nicor-ics@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 1, 2014
• Study Start: April 1, 2000
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 4, 2016

Record last verified: 2016-10

Locations

GB (10)