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Clinical study of one-stop transcatheter aortic valve replacement and percutaneous balloon mitral valve separation

Clinical study of one-stop transcatheter aortic valve replacement and percutaneous balloon mitral valve separation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066397
Enrollment
Unknown
Registered
2022-12-05
Start date
2022-12-05
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis combined with mitral stenosis

Interventions

Test group:Transcatheter mitral valve edge-to-edge repair

Sponsors

Department of Cardiology, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) age =75 years, STS-PROM/ EuroSCORE IIf > 8%; 2) patients with severe aortic stenosis (mean transaortic gradient =40 mmHg [1 mmHg=0.133 kPa], or transaortic flow velocity =4.0 m/s, or aortic valve orifice area 10 mmHg, or pulmonary artery systolic pressure > 50 mmHg); 4) NYHA grade =II; 5) patients who are anatomically suitable for transfemoral transcatheter aortic valve replacement and percutaneous balloon mitral valve separation; 6) patients who can understand the purpose of the experiment, sign the informed consent form, and are willing to accept the relevant clinical follow-up.

Exclusion criteria

Exclusion criteria: 1) Aortic root and mitral valve region anatomy and lesions are not suitable for prosthetic valve implantation or balloon dissection; 2) The presence of intracardiac mass, thrombus or vegetation by echocardiography; 3) Allergic to Nitinol, PET polyethylene terephthalate and other valve materials or contrast agents; They could not tolerate anticoagulant and antiplatelet therapy. 4) congenital aortic valve malformation (except bicuspid valve); 5) vascular diseases affecting device access; 6) only consents to undergo transcatheter aortic-valve replacement or percutaneous balloon mitral valve isolation.

Design outcomes

Primary

MeasureTime frame
All-cause mortality within 30 days;—

Secondary

MeasureTime frame
All-cause mortality, major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke), myocardial injury, and pacemaker implantation were recorded during the same hospitalization or within 7 days after the procedure;MACE within 30 days and cardiac readmission within 30 days;—

Countries

China

Contacts

Public ContactPeng Yong

West China Hospital, Sichuan University

pengyongcd@126.com18980606696

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026