Data Collecting and Analyzing of Different Treatment of Structural Heart DiseasesNCT02917980
Surgery and Transcatheter Intervention for Structural Heart Diseases
An observational study of Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases
- How many people
- 883 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with structural heart disease, whom received surgical,interventional or surgery combined with interventional hybrid treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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
- Keywords
- structural Heart Diseases, surgical treatment, interventional treatment, hybrid treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause
Measured: 12 months
Cumulative MACE
Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)
Measured: 12 months
Secondary outcomes (4)
Acute or chronic renal insufficiency
Measured: 12 months
residual shunt or regurgitation
Measured: 12 months
cerebral incidence
Measured: 12 months
hemolysis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2020
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Data Collecting and Analyzing of Different Treatment of Structural Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 883 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China, Beijing Anzhen Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917980
- Sponsor's protocol ID
- XJ-20160829
- Status last verified
- Sep 2016
- First submitted
- 27 Sep 2016
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Mao Y, Liu Y, Zhai M, Jin P, Chen F, Yang Y, Zhang G, Shang X, Jian Z, Zhang H, Wei L, Liu J, Guo Y, Pan X, Wu Y, Piazza N, Yang J. Treatment options for young patients with asymptomatic severe aortic stenosis: a multicenter retrospective cohort study. Eur J Med Res. 2025 Oct 14;30(1):966. doi: 10.1186/s40001-025-03227-6.
PubMed 41088494Liu Y, Xu C, Jin P, Zhai M, Tang H, Tian Z, Wen A, Qiao R, Yang J. Transcatheter closure of paravalvular leakage through multiple approaches after surgical mechanical valve replacements: A retrospective study. Medicine (Baltimore). 2024 Nov 22;103(47):e40600. doi: 10.1097/MD.0000000000040600.
PubMed 39809196Wang Y, Ma Y, Liu Y, Yang J. First Experience With a Novel Self-Expandable Valve for Mitral Annular Calcification Guided by Three-Dimensional Printing. Catheter Cardiovasc Interv. 2025 Mar;105(4):855-860. doi: 10.1002/ccd.31405. Epub 2025 Jan 7.
PubMed 39763352Jin P, Guo H, Mao Y, Zhai M, Liu Y, Yang J. Transcatheter mitral valve replacement to treat rheumatic mitral stenosis: a case series. Front Cardiovasc Med. 2024 Dec 5;11:1424105. doi: 10.3389/fcvm.2024.1424105. eCollection 2024.
PubMed 39703883Mao Y, Liu Y, Zhai M, Jin P, Zhang H, Wei L, Shang X, Guo Y, Pan X, Yang J. Prognostic value of right ventricular dysfunction in aortic regurgitation after transcatheter aortic valve replacement. Front Cardiovasc Med. 2024 Aug 30;11:1424116. doi: 10.3389/fcvm.2024.1424116. eCollection 2024.
PubMed 39280033Li L, Wang Y, Jin P, Yang T, Zhu G, Li Y, Tang J, Liu Y, Yang J. Hemodynamics in the treatment of pseudoaneurysm caused by extreme constriction of aortic arch with coated stent. Front Cardiovasc Med. 2024 Aug 20;11:1363230. doi: 10.3389/fcvm.2024.1363230. eCollection 2024.
PubMed 39228660Mao Y, Ma Y, Zhai M, Li L, Jin P, Liu Y, Yang J. Preliminary Study of a Degenerated Tricuspid Bioprosthetic Valve Implanted via Transcatheter Valve-in-Valve Implantation Guided by 3-Dimensional Printing. CJC Open. 2023 Dec 5;6(8):978-988. doi: 10.1016/j.cjco.2023.11.023. eCollection 2024 Aug.
PubMed 39211748Wang Y, Liu Y, Meng X, Zhai M, Jin P, Lu F, Yang J. Comparing outcomes of transcatheter tricuspid valve replacement and medical therapy for symptomatic severe tricuspid regurgitation: a retrospective study. Eur J Med Res. 2024 Aug 5;29(1):407. doi: 10.1186/s40001-024-01947-9.
PubMed 39103966Mao Y, Liu Y, Zhai M, Yang J. Application of and Prospects for 3-Dimensional Printing in Transcatheter Mitral Valve Interventions. Rev Cardiovasc Med. 2023 Feb 14;24(2):61. doi: 10.31083/j.rcm2402061. eCollection 2023 Feb.
PubMed 39077424Chen H, Mao Y, Xie H, Liu D, Zhang S, Tian Y, Yang J, Bai B. Case report: Cardiac metastatic uterine intravenous leiomyomatosis excision with extracorporeal venous shunt under the guidance of 3-dimensional printing. Front Cardiovasc Med. 2023 Jun 15;10:1117227. doi: 10.3389/fcvm.2023.1117227. eCollection 2023.
PubMed 37396586Mao Y, Liu Y, Meng X, Ma Y, Li L, Zhai M, Jin P, Lu F, Yang J. Treatment of severe tricuspid regurgitation induced by permanent pacemaker lead: Transcatheter tricuspid valve replacement with the guidance of 3-dimensional printing. Front Cardiovasc Med. 2023 Mar 22;10:1030997. doi: 10.3389/fcvm.2023.1030997. eCollection 2023.
PubMed 37034329Liu Y, Zhai M, Mao Y, Xu C, Ma Y, Li L, Jin P, Yang J. Transcatheter aortic valve replacement in patients with quadricuspid aortic valve in a single center. Front Cardiovasc Med. 2022 Sep 28;9:1011466. doi: 10.3389/fcvm.2022.1011466. eCollection 2022.
PubMed 36247444Mao Y, Liu Y, Ma Y, Jin P, Li L, Yang J. Mitral Valve-in-Valve Implant of a Balloon-Expandable Valve Guided by 3-Dimensional Printing. Front Cardiovasc Med. 2022 May 30;9:894160. doi: 10.3389/fcvm.2022.894160. eCollection 2022.
PubMed 35711355Xu C, Liu Y, Zhai M, Jin P, Li L, Ma Y, Yang J. Transcatheter Closure of a Paravalvular Leak Guided by Transesophageal Echocardiography and Three-Dimensional Printing. Front Cardiovasc Med. 2022 May 20;9:750896. doi: 10.3389/fcvm.2022.750896. eCollection 2022.
PubMed 35669478Ding P, Xu C, Liu Y, Meng X, Jin P, Tang J, Li L, Ma Y, Yang J. Application of three-dimensional transesophageal echocardiography in preoperative evaluation of transcatheter aortic valve replacement. BMC Cardiovasc Disord. 2021 Jun 28;21(1):315. doi: 10.1186/s12872-021-02101-7.
PubMed 34182931
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Registry Study of Surgery and Transcatheter Intervention for Structural Heart Diseases
- ClinicalTrials.gov ID
- NCT02917980
- Acronym / sponsor ID
- XJ-20160829
- Keywords
- structural Heart Diseases, surgical treatment, interventional treatment, hybrid treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 883 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China, Beijing Anzhen Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- Jan 2016
- Primary completion
- Jan 2020 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with structural heart disease, whom received surgical,interventional or surgery combined with interventional hybrid treatment
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death from any cause
Time frame: 12 months
Cumulative MACE
Time frame: 12 months
Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)
4 secondary outcomes
Acute or chronic renal insufficiency
Time frame: 12 months
residual shunt or regurgitation
Time frame: 12 months
cerebral incidence
Time frame: 12 months
hemolysis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 41088494Mao Y, Liu Y, Zhai M, Jin P, Chen F, Yang Y, Zhang G, Shang X, Jian Z, Zhang H, Wei L, Liu J, Guo Y, Pan X, Wu Y, Piazza N, Yang J. Treatment options for young patients with asymptomatic severe aortic stenosis: a multicenter retrospective cohort study. Eur J Med Res. 2025 Oct 14;30(1):966. doi: 10.1186/s40001-025-03227-6.
- Derived from this study: PubMed 39809196Liu Y, Xu C, Jin P, Zhai M, Tang H, Tian Z, Wen A, Qiao R, Yang J. Transcatheter closure of paravalvular leakage through multiple approaches after surgical mechanical valve replacements: A retrospective study. Medicine (Baltimore). 2024 Nov 22;103(47):e40600. doi: 10.1097/MD.0000000000040600.
- Derived from this study: PubMed 39763352Wang Y, Ma Y, Liu Y, Yang J. First Experience With a Novel Self-Expandable Valve for Mitral Annular Calcification Guided by Three-Dimensional Printing. Catheter Cardiovasc Interv. 2025 Mar;105(4):855-860. doi: 10.1002/ccd.31405. Epub 2025 Jan 7.
- Derived from this study: PubMed 39703883Jin P, Guo H, Mao Y, Zhai M, Liu Y, Yang J. Transcatheter mitral valve replacement to treat rheumatic mitral stenosis: a case series. Front Cardiovasc Med. 2024 Dec 5;11:1424105. doi: 10.3389/fcvm.2024.1424105. eCollection 2024.
- Derived from this study: PubMed 39280033Mao Y, Liu Y, Zhai M, Jin P, Zhang H, Wei L, Shang X, Guo Y, Pan X, Yang J. Prognostic value of right ventricular dysfunction in aortic regurgitation after transcatheter aortic valve replacement. Front Cardiovasc Med. 2024 Aug 30;11:1424116. doi: 10.3389/fcvm.2024.1424116. eCollection 2024.
- Derived from this study: PubMed 39228660Li L, Wang Y, Jin P, Yang T, Zhu G, Li Y, Tang J, Liu Y, Yang J. Hemodynamics in the treatment of pseudoaneurysm caused by extreme constriction of aortic arch with coated stent. Front Cardiovasc Med. 2024 Aug 20;11:1363230. doi: 10.3389/fcvm.2024.1363230. eCollection 2024.
- Derived from this study: PubMed 39211748Mao Y, Ma Y, Zhai M, Li L, Jin P, Liu Y, Yang J. Preliminary Study of a Degenerated Tricuspid Bioprosthetic Valve Implanted via Transcatheter Valve-in-Valve Implantation Guided by 3-Dimensional Printing. CJC Open. 2023 Dec 5;6(8):978-988. doi: 10.1016/j.cjco.2023.11.023. eCollection 2024 Aug.
- Derived from this study: PubMed 39103966Wang Y, Liu Y, Meng X, Zhai M, Jin P, Lu F, Yang J. Comparing outcomes of transcatheter tricuspid valve replacement and medical therapy for symptomatic severe tricuspid regurgitation: a retrospective study. Eur J Med Res. 2024 Aug 5;29(1):407. doi: 10.1186/s40001-024-01947-9.
- Derived from this study: PubMed 39077424Mao Y, Liu Y, Zhai M, Yang J. Application of and Prospects for 3-Dimensional Printing in Transcatheter Mitral Valve Interventions. Rev Cardiovasc Med. 2023 Feb 14;24(2):61. doi: 10.31083/j.rcm2402061. eCollection 2023 Feb.
- Derived from this study: PubMed 37396586Chen H, Mao Y, Xie H, Liu D, Zhang S, Tian Y, Yang J, Bai B. Case report: Cardiac metastatic uterine intravenous leiomyomatosis excision with extracorporeal venous shunt under the guidance of 3-dimensional printing. Front Cardiovasc Med. 2023 Jun 15;10:1117227. doi: 10.3389/fcvm.2023.1117227. eCollection 2023.
- Derived from this study: PubMed 37034329Mao Y, Liu Y, Meng X, Ma Y, Li L, Zhai M, Jin P, Lu F, Yang J. Treatment of severe tricuspid regurgitation induced by permanent pacemaker lead: Transcatheter tricuspid valve replacement with the guidance of 3-dimensional printing. Front Cardiovasc Med. 2023 Mar 22;10:1030997. doi: 10.3389/fcvm.2023.1030997. eCollection 2023.
- Derived from this study: PubMed 36247444Liu Y, Zhai M, Mao Y, Xu C, Ma Y, Li L, Jin P, Yang J. Transcatheter aortic valve replacement in patients with quadricuspid aortic valve in a single center. Front Cardiovasc Med. 2022 Sep 28;9:1011466. doi: 10.3389/fcvm.2022.1011466. eCollection 2022.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02917980, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.