Valvular Heart DiseaseSAVR-CT-AVANCT07125469
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
A study testing The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses in people with Valvular Heart Disease, run by Maria Cecilia Hospital at 1 site in Italy.
Trial summary
This study aims to understand why there may be differences between the measurements of the aortic valve taken before and during surgery. Specifically, it will compare the valve size suggested by a CT scan (Computed Tomography) with the size measured during the operation using surgical tools. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age 18 years or older
- All patients with isolated severe Aortic Stenosis (AS) considered eligible for Surgical Aortic Valve Replacement (SAVR) according to the current 2023 European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines for management of Valvular Heart Disease (reference 8) will be enrolled.
- Patient is willing to comply with study procedures and is available to return to the center for follow-up visits.
- Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate.
Who cannot join
- Bicuspid aortic valve anatomy Moderate to severe aortic valve regurgitation Multivalvular disease Redo Surgical Aortic Valve Replacement Ascending aorta aneurysm Aortic root enlargement Chronic Kidney Disease with estimated Glomerular Filtration Rate less than 30 milliliters per minute Body Mass Index greater than 30 kilograms per square meter Inadequate Multidetector Computed Tomography images
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Maria Cecilia Hospital
Cotignola, Ravenna, 48033
Elena Tenti, +390545217031, etenti@gvmnet.it
About this study
Official title: Intraoperative Assessment Versus Preoperative Multidetector Computed Tomography (MDCT) for Aortic Valve Annular Sizing in Surgical Aortic Valve Replacement (SAVR)"
This study aims to understand why there may be differences between the measurements of the aortic valve taken before and during surgery. Specifically, it will compare the valve size suggested by a CT scan (Computed Tomography) with the size measured during the operation using surgical tools. This will help determine which method is more accurate for selecting the right valve size in patients undergoing SAVR (Surgical Aortic Valve Replacement ).
- Conditions
- Valvular Heart Disease
- Being tested
- The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses
- Keywords
- valve size, Surgical Aortic Valve Replacement
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prosthesesOther
All patients with severe aortic stenosis (AS) who are scheduled for Surgical Aortic Valve Replacement (SAVR) with a bioprosthetic valve will undergo a pre-operative Computed Tomography (CT) scan. This CT scan will follow the pre-Transcatheter Aortic Valve Replacement (pre-TAVR) protocol and will focus only on imaging the aortic root, using a method called retrospective electrocardiogram (ECG) gating to capture detailed heart motion.
The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses:
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe AS and indication to SAVR with bioprosthetic valve | Other | Not described Receives: Other: The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic Valve Annular sizing in Surgical Aortic Valve Replacement
All patients with severe aortic stenosis (narrowing of the aortic valve) scheduled for Surgical Aortic Valve Replacement (SAVR), which is open-heart surgery to replace the valve with a bioprosthetic (tissue) valve, will have a pre-operative Computed Tomography (CT) scan. This CT scan follows the pre-Transcatheter Aortic Valve Replacement (pre-TAVR) protocol and focuses on the aortic root (the base of the aorta). It uses retrospective electrocardiogram (ECG) gating, a technique that times image capture with the heartbeat to get clear pictures of the heart.
Measured: pre-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start25 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fausto Castriota, Principal investigator, Maria Cecilia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125469
- Sponsor's protocol ID
- SAVR-CT-AVA
- Acronym
- SAVR-CT-AVA
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Assessment Versus Preoperative Multidetector Computed Tomography (MDCT) for Aortic Valve Annular Sizing in Surgical Aortic Valve Replacement (SAVR)"
- ClinicalTrials.gov ID
- NCT07125469
- Acronym / sponsor ID
- SAVR-CT-AVA / SAVR-CT-AVA
- Conditions
- Valvular Heart Disease
- Keywords
- valve size, Surgical Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to understand why there may be differences between the measurements of the aortic valve taken before and during surgery. Specifically, it will compare the valve size suggested by a CT scan (Computed Tomography) with the size measured during the operation using surgical tools. This will help determine which method is more accurate for selecting the right valve size in patients undergoing SAVR (Surgical Aortic Valve Replacement ).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe AS and indication to SAVR with bioprosthetic valve | Other | Other: The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age 18 years or older
- All patients with isolated severe Aortic Stenosis (AS) considered eligible for Surgical Aortic Valve Replacement (SAVR) according to the current 2023 European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines for management of Valvular Heart Disease (reference 8) will be enrolled.
- Patient is willing to comply with study procedures and is available to return to the center for follow-up visits.
- Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate.
Key exclusion criteria (1 listed)
- Bicuspid aortic valve anatomy Moderate to severe aortic valve regurgitation Multivalvular disease Redo Surgical Aortic Valve Replacement Ascending aorta aneurysm Aortic root enlargement Chronic Kidney Disease with estimated Glomerular Filtration Rate less than 30 milliliters per minute Body Mass Index greater than 30 kilograms per square meter Inadequate Multidetector Computed Tomography images
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prosthesesAll patients with severe aortic stenosis (AS) who are scheduled for Surgical Aortic Valve Replacement (SAVR) with a bioprosthetic valve will undergo a pre-operative Computed Tomography (CT) scan. This CT scan will follow the pre-Transcatheter Aortic Valve Replacement (pre-TAVR) protocol and will focus only on imaging the aortic root, using a method called retrospective electrocardiogram (ECG) gating to capture detailed heart motion. The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses: | Other | Patients with severe AS and indication to SAVR with bioprosthetic valve |
Primary outcome
Aortic Valve Annular sizing in Surgical Aortic Valve Replacement
Time frame: pre-operative
All patients with severe aortic stenosis (narrowing of the aortic valve) scheduled for Surgical Aortic Valve Replacement (SAVR), which is open-heart surgery to replace the valve with a bioprosthetic (tissue) valve, will have a pre-operative Computed Tomography (CT) scan. This CT scan follows the pre-Transcatheter Aortic Valve Replacement (pre-TAVR) protocol and focuses on the aortic root (the base of the aorta). It uses retrospective electrocardiogram (ECG) gating, a technique that times image capture with the heartbeat to get clear pictures of the heart.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fausto Castriota principal investigator
Maria Cecilia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The measurements taken from the CT scan will be used to determine the appropriate size for two types of theoretical Transcatheter Aortic Valve Replacement (TAVR) prostheses in people with Valvular Heart Disease, run by Maria Cecilia Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Tenti (+39 0545217031, etenti@gvmnet.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic Valve Annular sizing in Surgical Aortic Valve Replacement (time frame: pre-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.