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Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection

NCT05844969 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-04-22

No results posted yet for this study

Summary

The goal of this non-interventional, retrospective data analysis is to validate the circle method for patients with bicuspid aortic heart valves undergoing transcatheter aortic heart valve implantation (TAVI).

The main aims are:

* to assess whether patients with bicuspid aortic valves that received a TAVI suffered from fewer complications

* if valve size was identical to the one determined using the circle method compared to
* a case where circle method derived valve size is different from the actually implanted valve
* to develop recommendations on how to size the valve using the circle method.

Conditions

  • Aortic Stenosis With Bicuspid Valve

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • Institut für Pharmakologie und Präventive Medizin

    lead NETWORK

Principal Investigators

  • Pierluigi Costanzo, Dr. · Royal Papworth Hospital NHS Foundation Trust

  • Ioannis Lianos, Dr. · Guy's and St Thomas NHS Foundation Trust

  • Tiffany Patterson, Dr. · Guy's and St Thomas NHS Foundation Trust

  • Timothy Bagnall, Dr. · University Hospitals Sussex NHS Foundaton Trust

  • Angie Ghattas, Dr. · Golden Jubilee National Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • United Kingdom

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 NCT05844969 on ClinicalTrials.gov