Skip to main content
OpenTrials
Completed

NCT Number: NCT02917980

Surgery and Transcatheter Intervention for Structural Heart Diseases

This project aimed to optimize the therapeutic strategy for structural heart disease by choosing optimal treatment, such as,surgical treatment,interventional and surgery combined with interventional hybrid treatment. Thereby improve successful rate of clinical treatment, and establish the guideline for treatment of structural heart disease.At the same time,online registration database for structural heart disease will be established to further data analysis and objective assessment of clinical curative effect for structural heart disease in China.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital

Xi'an, Shaan'xi Province, 710032, China

About this study

This project is a 5 years prospective,observational,longitudinal registration study on clinical surgical and interventional treatment of structural heart disease.Firstly,patients with structural heart disease, whom received surgical,interventional or surgery combined with interventional hybrid treatment during Jan. 2015 to Jan. 2020 ,were registrated dynamiclly. And further management and 1 year clinical follow-up,which contains demographic characteristics, clinical manifestations, treatment strategies and prognosis of outcome, were performed on the recruited data.Secondly, this is also a prospective observational study, featured by collecting data through annual follow-up,with the timing at the point of off the hospital,and 1,2,6,9,12 month after hospital discharge,respectively.

The inclusion criteria:

  • atrial septal defect
  • ventricular septal defect
  • patent ductus arteriosis
  • pulmonary stenosis
  • residual leakage after surgical treatment for congenital heart disease
  • coronary artery fistula
  • pulmonary arteriovenous malformations
  • tetralogy of Fallot, and other cyanotic heart disease
  • mitral stenosis and insufficiency
  • tricuspid stenosis and insufficiency
  • aortic stenosis and insufficiency
  • pulmonary stenosis and insufficiency
  • coarctation of aorta
  • paravalvular leakage
  • hypertrophic obstructive heart disease
  • dilated cardiomyopathy
  • structural heart disease need surgery combined with interventional hybrid treatment
  • structural heart disease need surgeryor interventional treatment

The exclusion criteria:

  • primary arrhythmia cardiac disease,like tachycardia and ventricular fibrillation
  • circulation disease, like coronary heart disease,hypertension,arterial aneurysm
  • patients were not received any treatment
  • patients were hard to follow-up
  • no informed Consent

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.atrial septal defect 20ventricular septal defect 3.patent ductus arteriosis 4.pulmonary stenosis 5.residual leakage after surgical treatment for congenital heart disease 6.coronary artery fistula 7.pulmonary arteriovenous malformations 8.tetralogy of Fallot, and other cyanotic heart disease 9.mitral stenosis and insufficiency 10.tricuspid stenosis and insufficiency 11.aortic stenosis and insufficiency 12.pulmonary stenosis and insufficiency 13.coarctation of aorta 14.paravalvular leakage 15.hypertrophic obstructive heart disease 16.dilated cardiomyopathy 17.structural heart disease need surgery combined with interventional hybrid treatment 18.structural heart disease need surgeryor interventional treatment

Exclusion criteria

  • primary arrhythmia cardiac disease,like tachycardia and ventricular fibrillation
  • circulation disease, like coronary heart disease,hypertension,arterial aneurysm
  • patients were not received any treatment
  • patients were hard to follow-up
  • no informed Consent

Treatment and study plan

Primary outcomes

  1. Death from any cause

    Time frame: 12 months

  2. Cumulative MACE

    Time frame: 12 months

    Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)

Secondary outcomes

  1. Acute or chronic renal insufficiency

    Time frame: 12 months

  2. residual shunt or regurgitation

    Time frame: 12 months

  3. cerebral incidence

    Time frame: 12 months

  4. hemolysis

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Collaborators

  • Beijing Anzhen Hospital
  • Fu Wai Hospital, Beijing, China
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

Multicenter Registry Study of Surgery and Transcatheter Intervention for Structural Heart Diseases

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Sep 28, 2016
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.