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Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease

NCT07605624 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5500

Last updated 2026-05-26

No results posted yet for this study

Summary

This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.

Conditions

  • Aortic Stenosis
  • Aortic Regurgitation
  • Mitral Regurgitation
  • Tricuspid Regurgitation

Interventions

DEVICE

Transcatheter Aortic Valve Replacement

Transcatheter Aortic Valve Replacement

DEVICE

Transcatheter Edge-to-Edge Repair

Transcatheter Edge-to-Edge Repair

DEVICE

Transcatheter Tricuspid Valve Annuloplasty

Transcatheter Tricuspid Valve Annuloplasty

DEVICE

Surgical Aortic Valve Replacement

Surgical Aortic Valve Replacement

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-10
Primary Completion
2029-01-31
Completion
2029-01-31
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07605624 on ClinicalTrials.gov