Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 16937 for:    "Heart Diseases"

Surgery and Transcatheter Intervention for Structural Heart Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02917980
Recruitment Status : Recruiting
First Posted : September 28, 2016
Last Update Posted : September 28, 2016
Sponsor:
Collaborators:
Fu Wai Hospital, Beijing, China
Beijing Anzhen Hospital
Wuhan Union Hospital, China
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:
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.

Condition or disease
Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases

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

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Multicenter Registry Study of Surgery and Transcatheter Intervention for Structural Heart Diseases
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with structural heart disease, whom received surgical,interventional or surgery combined with interventional hybrid treatment
Criteria

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

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): NCT02917980


Contacts
Layout table for location contacts
Contact: Jian Yang, M.D Ph.D 13892828016 yangjian1212@hotmail.com
Contact: Jiayou Tang, M.D Ph.D 15353618121 dr_shaddock@163.com

Locations
Layout table for location information
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Jian Yang, M.D Ph.D    13892828016    yangjian1212@hotmail.com   
Contact: Jiayou Tang, M.D Ph.D    15353618121    tjy-heart@outlook.com   
Sponsors and Collaborators
Xijing Hospital
Fu Wai Hospital, Beijing, China
Beijing Anzhen Hospital
Wuhan Union Hospital, China

Additional Information:

Layout table for additonal information
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02917980     History of Changes
Other Study ID Numbers: XJ-20160829
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Xijing Hospital:
structural Heart Diseases
surgical treatment
interventional treatment
hybrid treatment

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases