Clinical trial NCT05844969: Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection
Official title: Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection to Validate Circle Method for Sizing and Positioning in Bicuspid Aortic Valves
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Stenosis With Bicuspid Valve
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2023-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with bicuspid valve disease who underwent aortic valve replacement.

Brief 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.

Detailed description: The bicuspid aortic valve (BAV) is the most common heart valve abnormality and is associated with a number of cardiac complications, including infective endocarditis, aortic dissection, aortic dilatation, and the development of severe aortic stenosis (AS). Due to its anatomical characteristics BAV has been considered a contraindication to transcatheter aortic valve implantation (TAVI), a standard treatment of AS. However, several recent trials have presented promising results indicating TAVI to be a safe alternative to surgery for low risk patients and more patients with BAV have been considered for TAVI.

There are several sizing techniques for TAVI in BAV, including an annular sizing, a supra-annular sizing, and a balloon sizing, yet there is still no consensus on the most appropriate technique. Although annular sizing remains the major approach in most patients with BAV, some BAV anatomies may profit from the supra-annular sizing. Recently published consensus for sizing and positioning the balloon-expandable Edwards SAPIEN 3 transcatheter heart valve (THV) in BAV describes the anatomical features that influence sizing optimization. The novel circle technique has also been proposed in the presence of the unique anatomical factors and sizing at the supra-annular level. This method is particularly helpful for visually identifying anatomic features, indicating the sealing zone at the commissures, visually reassuring of the size and position, and treating patients with large annuli. Currently, there are limited data validating the circle method for identifying sizing and positioning for TAVI in BAV patients.

In this non-interventional, retrospective, multicenter data collection and analysis we aim to validate the circle method for sizing and positioning in bicuspid aortic valves.

Due to the non-interventional character of the project, no additional burden will be put on the patients eligible for inclusion.

Eligibility criteria: Inclusion Criteria:

* Patients with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra)
* Computed Tomography data available

Exclusion Criteria:

- none

Primary outcomes:
measure: Complications
timeFrame: 12 months
Secondary outcomes:
measure: Sizing with Circle Method
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Foundation Trust
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas NHS Foundation Trust
city: Worthing
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust
Study officials:
affiliation: Royal Papworth Hospital NHS Foundation Trust
name: Pierluigi Costanzo, Dr.
role: STUDY_DIRECTOR
affiliation: Guy's and St Thomas NHS Foundation Trust
name: Ioannis Lianos, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Guy's and St Thomas NHS Foundation Trust
name: Tiffany Patterson, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Sussex NHS Foundaton Trust
name: Timothy Bagnall, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Golden Jubilee National Hospital
name: Angie Ghattas, Dr.
role: PRINCIPAL_INVESTIGATOR
References: