Surgery and Transcatheter Intervention for Structural Heart Diseases

January 10, 2023 updated by: Xijing Hospital

Multicenter Registry Study of 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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:

  1. atrial septal defect
  2. ventricular 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

The exclusion criteria:

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

Study Type

Observational

Enrollment (Actual)

883

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with structural heart disease, whom received surgical,interventional or surgery combined with interventional hybrid treatment

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
surgical treatment
patients with structural heart disease received surgical treatment
interventional treatment
patients with structural heart disease received interventional treatment
surgical combined with interventional treatment
patients with structural heart disease received surgical combined with interventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative MACE
Time Frame: 12 months
Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)
12 months
Death from any cause
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute or chronic renal insufficiency
Time Frame: 12 months
12 months
residual shunt or regurgitation
Time Frame: 12 months
12 months
cerebral incidence
Time Frame: 12 months
12 months
hemolysis
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Beijing Anzhen Hospital
Wuhan Union Hospital, China
Fu Wai Hospital, Beijing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJ-20160829

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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