Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection
NCT ID: NCT05844969
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
60 participants
OBSERVATIONAL
2025-06-01
2025-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+
NCT07217691
Optimized Expansion of the Implanted Transcatheter Aortic Valve
NCT07042529
Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement
NCT07125469
Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation
NCT05672823
Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome - (German Pilot)
NCT03570190
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Computed Tomography data available
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Edwards Lifesciences
INDUSTRY
Institut für Pharmakologie und Präventive Medizin
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pierluigi Costanzo, Dr.
Role: STUDY_DIRECTOR
Royal Papworth Hospital NHS Foundation Trust
Ioannis Lianos, Dr.
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas NHS Foundation Trust
Tiffany Patterson, Dr.
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas NHS Foundation Trust
Timothy Bagnall, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Sussex NHS Foundaton Trust
Angie Ghattas, Dr.
Role: PRINCIPAL_INVESTIGATOR
Golden Jubilee National Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Golden Jubilee National Hospital
Clydebank, , United Kingdom
Guy's and St Thomas NHS Foundation Trust
London, , United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CMOP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.