Aortic Valve RegurgitationPERCEVALNCT05799573
CT Scan Sizing for Perceval Sutureless Valve
An observational study of Aortic Valve Regurgitation, run by Maria Cecilia Hospital at 1 site in Italy.
Trial summary
The Perceval sutureless aortic bioprosthesis is a bovine pericardium valve mounted in a nitinol stent that can be compressed and positioned in a valve delivery system. Similarly, to transcatheter aortic valve implantation (TAVI) devices, the anchoring and good sealing of the Perceval bioprosthesis relies on oversizing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Regurgitation
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients with indication for aortic valve replacement with a Perceval valve
Who may be able to join
- Male and female subjects > 18 years;
- Subjects willing to sign and date an informed consent for treatment of personal data;
- Subjects willing and able to comply with the follow up schedule of the protocol;
- Subjects with indication for aortic valve replacement on a tricuspid aortic valve;
- Subjects with possibly associated need for coronary revascularization.
- Subjects with Ejection Fraction ≥ 40%
Who cannot join
- Male and female subjects ≤ 18 years;
- Subjects with bicuspid aortic valve
- Subjects with associated mitral valvulopathy or ascending aorta aneurysm
- Subjects with pure aortic insufficiency
- Subjects with Ejection Fraction < 40%
- Subjects with acute myocardial infarction < 30 gg
- Subjects with serum creatinine > 2 mg/Dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT-scan Sizing Perceval Sutureless Valve
The Perceval sutureless aortic bioprosthesis is a bovine pericardium valve mounted in a nitinol stent that can be compressed and positioned in a valve delivery system. Similarly, to transcatheter aortic valve implantation (TAVI) devices, the anchoring and good sealing of the Perceval bioprosthesis relies on oversizing by design of the nitinol stent compared with the native aortic annulus. With the advent of TAVI, cardiac computed tomography (CT) has become the gold standard technique for measuring the aortic annulus in patients undergoing transcatheter procedures, and the CT-derived axial image of the aortic virtual basal ring (VBR) is considered as the reference for sizing by most of the manufacturers of transcatheter valves .
Interestingly, the VBR lies exactly on the plane passing through the nadir of the 3 aortic cusps, that is where, according to the instructions for use, a correctly positioned Perceval valve should be deployed. VBR could then provide a good estimate of the annular dimension for the Perceval pre-operative sizing.
Read the detailed description
Recent evidence in TAVI patients suggests that significant underexpansion or distortion of valved stents may be associated with altered leaflet function, leading to increased transprosthetic gradients and possibly predisposing to other negative outcomes such as valve thrombosis, low platelet counts, thromboembolic events, and early degeneration . Moreover, there is evidence that excessive oversizing of the Perceval valve is detrimental.
The present study is aimed to investigate the relationship between the CT-derived measure of the annulus dimension and early hemodynamic and clinical outcomes in patients undergoing sutureless aortic valve replacement (AVR) with the Perceval sutureless aortic valve and define the Perceval sizing chart based on preoperative CT-scan measurements.
- Conditions
- Aortic Valve Regurgitation
- Medical subject headings
- Aortic Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge
The primary endpoint is to evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge in terms of:
- Mean and peak pressure gradients
- Prosthetic regurgitation
- migration/dislodgement
- need for permanent pacemaker implant
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Dec 2022
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve RegurgitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Mikus, MD, Principal investigator, Maria Cecilia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799573
- Sponsor's protocol ID
- PERCEVAL
- Acronym
- PERCEVAL
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information related to the participation of a subject in this study will be treated with the utmost confidentiality, in accordance with good clinical practice (Decree of the Ministry of Health of 15 July 1997, and subsequent amendments and additions) and regulations on the protection of personal data: Information and Consent pursuant to Legislative Decree no. 196 of 30/06/2003 and the European General Data Protection Regulation (GDPR - General Data Protection Regulation), which came into force on 25 May 2018. All patient names will be kept confidential. Patients will be identified throughout documentation and evaluation by the number allotted to them by the study. The patients will be assured that all findings will be stored on computer and handled in the strictest confidence. The Investigator agrees to maintain the confidentiality of the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-scan Sizing Perceval Sutureless Valve
- ClinicalTrials.gov ID
- NCT05799573
- Acronym / sponsor ID
- PERCEVAL / PERCEVAL
- Conditions
- Aortic Valve Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 5 Apr 2023 (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.
The Perceval sutureless aortic bioprosthesis is a bovine pericardium valve mounted in a nitinol stent that can be compressed and positioned in a valve delivery system. Similarly, to transcatheter aortic valve implantation (TAVI) devices, the anchoring and good sealing of the Perceval bioprosthesis relies on oversizing by design of the nitinol stent compared with the native aortic annulus. With the advent of TAVI, cardiac computed tomography (CT) has become the gold standard technique for measuring the aortic annulus in patients undergoing transcatheter procedures, and the CT-derived axial image of the aortic virtual basal ring (VBR) is considered as the reference for sizing by most of the manufacturers of transcatheter valves .
Interestingly, the VBR lies exactly on the plane passing through the nadir of the 3 aortic cusps, that is where, according to the instructions for use, a correctly positioned Perceval valve should be deployed. VBR could then provide a good estimate of the annular dimension for the Perceval pre-operative sizing.
Detailed description
Recent evidence in TAVI patients suggests that significant underexpansion or distortion of valved stents may be associated with altered leaflet function, leading to increased transprosthetic gradients and possibly predisposing to other negative outcomes such as valve thrombosis, low platelet counts, thromboembolic events, and early degeneration . Moreover, there is evidence that excessive oversizing of the Perceval valve is detrimental.
The present study is aimed to investigate the relationship between the CT-derived measure of the annulus dimension and early hemodynamic and clinical outcomes in patients undergoing sutureless aortic valve replacement (AVR) with the Perceval sutureless aortic valve and define the Perceval sizing chart based on preoperative CT-scan measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for aortic valve replacement with a Perceval valve
Key inclusion criteria (6 listed)
- Male and female subjects > 18 years;
- Subjects willing to sign and date an informed consent for treatment of personal data;
- Subjects willing and able to comply with the follow up schedule of the protocol;
- Subjects with indication for aortic valve replacement on a tricuspid aortic valve;
- Subjects with possibly associated need for coronary revascularization.
Key exclusion criteria (7 listed)
- Male and female subjects ≤ 18 years;
- Subjects with bicuspid aortic valve
- Subjects with associated mitral valvulopathy or ascending aorta aneurysm
- Subjects with pure aortic insufficiency
- Subjects with Ejection Fraction < 40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge
Time frame: 12 months
The primary endpoint is to evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge in terms of: * Mean and peak pressure gradients * Prosthetic regurgitation * migration/dislodgement * need for permanent pacemaker implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. All information related to the participation of a subject in this study will be treated with the utmost confidentiality, in accordance with good clinical practice (Decree of the Ministry of Health of 15 July 1997, and subsequent amendments and additions) and regulations on the protection of personal data: Information and Consent pursuant to Legislative Decree no. 196 of 30/06/2003 and the European General Data Protection Regulation (GDPR - General Data Protection Regulation), which came into force on 25 May 2018. All patient names will be kept confidential. Patients will be identified throughout documentation and evaluation by the number allotted to them by the study. The patients will be assured that all findings will be stored on computer and handled in the strictest confidence. The Investigator agrees to maintain the confidentiality of the study protocol.
Related trials for Aortic Valve Regurgitation
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SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
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Echocardiographic Perspectives on Transient Mitral Regurgitation After Septal Myectomy
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ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Aortic Valve Insufficiency, Aortic Valve Stenosis
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. This study is not recruiting at the moment.
Elisa Mikus, MD 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?
An observational study of Aortic Valve Regurgitation, 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge (time frame: 12 months). 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 13 May 2026.