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Clinical application study of new interventional therapy for perivalvular leakage assisted by 3D printing

Clinical application study of new interventional therapy for perivalvular leakage assisted by 3D printing

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052882
Enrollment
Unknown
Registered
2021-11-06
Start date
2021-11-30
Completion date
Unknown
Last updated
2022-08-23

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

Conditions

Perivalvular leak

Interventions

Interventional Therapy New Technology Group:No
Traditional Surgery Group:No

Sponsors

Fuwai Hospital, CAMS & PUMC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. Transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) confirmed the presence of postoperative residual fistula/perivalvular leakage of congenital heart disease and valvular disease requiring surgical reintervention as assessed by the surgeon; 3. There were no other contraindications for transcatheter intervention.

Exclusion criteria

Exclusion criteria: 1. Patients with other cardiovascular diseases requiring surgical intervention; 2. Patients with nausea tumor or other diseases with life expectancy of less than 2 years; 3. Patients who cannot be followed up during the study period, patients with other systemic reasons can not tolerate interventional surgery; 4. Patients with other reasons; patients who participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Success rate of interventional surgery;Surgical success rate;

Secondary

MeasureTime frame
Residual diffluence;Complication;

Countries

China

Contacts

Public ContactHu Haibo

Fuwai Hospital, CAMS & PUMC

hhb.fwhospital@hotmail.com+86 13366458604

Outcome results

None listed

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