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

April 17, 2025 updated by: Institut für Pharmakologie und Präventive Medizin

Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection to Validate Circle Method for Sizing and Positioning in Bicuspid Aortic Valves

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 12 months

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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sizing with Circle Method
Time Frame: 12 months
To develop recommendations on how to size the valve using the circle method.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Pharmakologie und Präventive Medizin

Collaborators

Edwards Lifesciences

Investigators

  • Study Director: Pierluigi Costanzo, Dr., Royal Papworth Hospital NHS Foundation Trust
  • Principal Investigator: Ioannis Lianos, Dr., Guy's and St Thomas NHS Foundation Trust
  • Principal Investigator: Tiffany Patterson, Dr., Guy's and St Thomas NHS Foundation Trust
  • Principal Investigator: Timothy Bagnall, Dr., University Hospitals Sussex NHS Foundaton Trust
  • Principal Investigator: Angie Ghattas, Dr., Golden Jubilee National Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only anonymized, aggregated data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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