severe aortic regurgitation (AR)
Conditions
Interventions
Experimental group:Implanting the prosthesis of arotic valve
Sponsors
Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with pure severe AR diagnosed by transthoracic echocardiography; 2. Aged > 65 years; 3. Patients with high risk and contraindications to surgery; 4. CT indicators are complete; 5. Patients who voluntarily participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Other clinical factors make it impossible to perform TAVR or SAVR, such as: EF 70mm; 2. Other TAVR contraindications; 3. The patient has poor compliance and cannot complete the study as required; 4. Those who have participated in other interventional clinical trials (within the past 30 days).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TAVR device implantation success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of TAVR procedure;Rate of postoperative AR<=2+ patients;Rate of postoperative hospitalization for heart failure;Postoperative NYHA New York heart function class I or II rate;Improvement in 6-minute walk distance from baseline;Improvement in BNP/NT-proBNP from baseline;Echocardiographic left ventricular end-diastolic volume (LVEDV) change from baseline;Changes in quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score;Incidence of major adverse events (MACCEs);All-cause mortality;Cardiogenic mortality;Postoperative readmission rate for heart failure; | — |
Countries
China
Contacts
Public ContactSong Guangyuan
Outcome results
None listed