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A prospective cohort study of transcatheter valve in valve technique for surgical bioprosthesis failure

A prospective cohort study of transcatheter valve in valve technique for surgical bioprosthesis failure

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063079
Enrollment
Unknown
Registered
2022-08-30
Start date
2022-08-31
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

heart valve disease

Interventions

Group 1 :
Group 2:

Sponsors

Tianjin Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. New York Heart Association (NYHA) Class II and above; 2. Definition of BVF: Permanent valve structural degeneration that causes hemodynamic changes or valve leaflet dysfunction, including calcification, valve leaflet thickening, tearing, wear, stent shedding, permanent thrombosis and other reasons. Patients with stage 2 and above structural valvular degeneration should receive a second operation: patients with moderate or greater stenosis or insufficiency of the valve caused by reversible thrombus should be excluded; Valve pressure difference > 40 mmHg), accompanied by a decrease in effective valve area and a change in flow velocity (peak flow velocity > 4 m/s); 3. STS (Society of Thoracic Surgeons, STS) score >= 4%.

Exclusion criteria

Exclusion criteria: 1. Valve function recovery after standard anticoagulant therapy; paravalvular disease; 2. Combined with severe coronary artery disease requiring revascularization or evidence of acute myocardial infarction within one month (Q wave myocardial infarction, or non-Q wave myocardial infarction, accompanied by CK-MB >= twice the normal value or T elevation); 3. Left ventricular ejection fraction < 20%; 4. Recent cerebral embolism; 5. Renal failure (serum creatinine clearance < 20 ml/min); 6. Hemorrhagic constitution or coagulation dysfunction, sepsis; 7. Life expectancy < 1 year; 8. There are uncontrolled atrial or ventricular arrhythmias.

Design outcomes

Primary

MeasureTime frame
30 day mortality;Prosthesis-patient mismatch;

Countries

China

Contacts

Public ContactNan Jiang

Tianjin Chest Hospital

jiangnantj@126.com+86 13821155802

Outcome results

None listed

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