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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut für Pharmakologie und Präventive Medizin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra)

Computed Tomography data available

Disqualifiers

None

Trial population

Adult patients with bicuspid valve disease who underwent aortic valve replacement.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Complications

To assess whether patients with bicuspid aortic valves that received a SAPIEN 3 / Ultra THV 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

Time frame
12 months

Secondary outcomes

1

Sizing with Circle Method

To develop recommendations on how to size the valve using the circle method.

Time frame
12 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: