The Second Affiliated Hospital Zhejiang University School of Medicine.
Hangzhou, Zhejiang, 310006, China
Location status: Recruiting
NCT Number: NCT04954404
The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310006, China
Location status: Recruiting
Prospective, single-arm, single-center clinical evaluation of transcatheter mitral valve intervention in subjects with mitral valve disease who are treated per standard of care and who have been determined by the local heart team as appropriate for interventional treatment. Eligible subjects will be treated by transcatheter mitral valve repair or transcatheter mitral valve replacement.
This single-arm registry will provide valuable new information regarding use of multiple mitral valve interventional devices and evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
transcatheter mitral valve repair/transcatheter mitral valve replacement
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Death from any causes including both cardiovascular and non-cardiovascular.
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Death from any cardiovascular events.
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Number of patients readmission for recurrent Heart Failure.
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge
Number and volumes of new brain lesions detected by Magnetic Resonance Imaging (MRI) after procedure with or without clinical symptom.
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Immediately after procedure
Defined according to consensus document from the mitral valve academic research consortium (MVARC).
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Number of patients with infective endocarditis.
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Number of patients hospitalized for≥24h. Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition according to MVARC.
Time frame: Predischarge, 30 days
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Change of NYHA status from baseline to each follow-up.
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
The change in MR and/or MS severity from baseline to each follow-up.
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Improvement in quality of life from baseline to each follow-up measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Change of cognitive function from baseline to each follow-up measured by the Mini-mental State Examination (MMSE).
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
The change in 6-min walk test distance from baseline to each follow-up.
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Any conditions need reintervention or surgery, as device-related thrombosis, valve deterioration.
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Number of patients reported as clinically significant iASD requiring ASD closure.
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Time frame: Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
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.
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