Stenoses, Aortic ValveNCT07116265
Perceval Aortic Bioprostheses : Durability Study.
An observational study of Stenoses, Aortic Valve and Aortic Insufficiency, run by University Hospital, Montpellier.
Trial summary
Aortic valve replacement is one of the most commonly performed procedures in adult cardiac surgery in France. Patients over the age of 65 most often receive a bioprosthetic aortic valve during an isolated aortic valve replacement or in combination with another cardiac surgery, which may extend the operative time. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stenoses, Aortic Valve, Aortic Insufficiency, Aortic Diseases
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Jan 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe or non-severe aortic disease, symptomatic or asymptomatic, who received a rapidly deployed Perceval aortic bioprosthesis between January 1, 2012, and January 31, 2023, in the cardiac surgery department at Montpellier University Hospital.
Who may be able to join
- Patients with severe or non-severe aortic stenosis, symptomatic or asymptomatic, who received a rapidly deployed Perceval aortic bioprosthesis between January 1, 2012, and January 31, 2023, in the cardiac surgery department at Montpellier University Hospital.
Who cannot join
- Perceval bioprosthesis explanted during the same surgical procedure.
- History of aortic root surgery.
About this study
Official title: Long Term Clinical and Hemodynamic Follow-up of the Sutureless Perceval Bioprothesis
Aortic valve replacement is one of the most commonly performed procedures in adult cardiac surgery in France.
Patients over the age of 65 most often receive a bioprosthetic aortic valve during an isolated aortic valve replacement or in combination with another cardiac surgery, which may extend the operative time.
Read more
The Perceval bioprosthesis has the advantage to reduce operative time due to its automatic deployment on a stent, which shortens the suturing time compared to other bioprostheses that require more sutures (sutureless valve).
In this retrospective, single-center, observational descriptive study, the investigators are conducting a follow-up of 193 patients operated on at the Montpellier University Hospital between January 2012 and January 2023, who received a Perceval aortic valve as part of routine annual follow-up, in order to assess the durability of this valve based on clinical and echocardiographic Valve Academic Research Consortium 3 (VARC-3) criteria.
Read the detailed description
Exclusion Criteria :
Perceval bioprosthesis explanted during the same surgical procedure. History of aortic root surgery.
Primary Endpoint :
- Survival free from valve degeneration, according to VARC-3 criteria for structural or non-structural valve dysfunction.
Secondary endpoints :
- Freedom from aortic valve reintervention
- Freedom from SVD
- Freedom from permanent pacemaker implantation
- Freedom from stroke or transient ischemic attack
- Freedom from cardiac related rehospitalization
- Cardiac-specific mortality
Preoperative clinical data are collected via the DxCare electronic medical record system (including weight, height, medical history, and cardiovascular risk factors). Surgical data (type of procedure, operative time, outcomes at the end of surgery) are also extracted from the same software.
Follow-up Procedures :
Included patients are systematically scheduled for a cardiology follow-up consultation as part of routine annual postoperative care at the university hospital or in private practice. During this visit, they undergo a transthoracic echocardiography and a clinical assessment of their health status. These data are collected for analysis.
If patients are not followed up at the hospital and are considered lost to follow-up, their referring cardiologist will be contacted to obtain the most recent cardiological health data.
The annual follow-up echocardiography focuses on evaluating the hemodynamic parameters and durability of the bioprosthesis (presence or absence of pathological regurgitation, leaflet immobility, or thickening).
Clinical status is also assessed during the annual follow-up, including symptoms such as dyspnea, chest pain, and limitations in daily activities.
As part of standard follow-up, patients are contacted by phone and informed of the purpose of their scheduled visit to the Montpellier University Hospital.
For patients unable to attend an in-person consultation, a telephone interview is conducted to assess their clinical status, and their cardiologist is contacted to provide the most recent echocardiography report and clinical follow-up data. For patients who died before the beginning of the study, their trusted contact is approached to obtain clinical information regarding their medical history prior to death.
- Keywords
- perceval, durability, degeneration, pacemaker
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Aortic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
survival without Bioprosthetic Valve Failure
Measured: From enrollment to the last news (up to 130 months) or death
Secondary outcomes (6)
Survival without reoperation
Measured: From enrollment to the last news (up to 130 months) or death
Survival without structural valve deterioration
Measured: From enrollment to the last news (up to 130 months) or death
survival without pacemaker implantation
Measured: From enrollment to the last news (up to 130 months) or death
survival without stroke
Measured: From enrollment to the last news (up to 130 months) or death
Survival without rehospitalization for cardiac origin
Measured: From enrollment to the last news (up to 130 months) or death
Survival without death for cardiac origin
Measured: From enrollment to the last news (up to 130 months) or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jan 2012
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stenoses, Aortic ValveStudies 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
- Other
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116265
- Sponsor's protocol ID
- IRB-MTP_2023_07_202301441
- Status last verified
- Aug 2025
- First submitted
- 3 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
31. Fischlein T, Meuris B, Hakim-Meibodi K, Misfeld M, Carrel T, Zembala M, et al. The sutureless aortic valve at 1 year: A large multicenter cohort study. JTCVS. (2016) ; 151(6):1617-1626.e4. 32. Fischlein T, Meuris B, Folliguet T, Hakim-Meibodi K, Misfeld M, Carrel T, et al. Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study. JTCVS. (2022) ; 164(6):1772-1780.e11. 35. Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, et al. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. JACC. (2021) ; 77(21):2717-46.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Clinical and Hemodynamic Follow-up of the Sutureless Perceval Bioprothesis
- ClinicalTrials.gov ID
- NCT07116265
- Acronym / sponsor ID
- IRB-MTP_2023_07_202301441
- Keywords
- perceval, durability, degeneration, pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 11 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.
Aortic valve replacement is one of the most commonly performed procedures in adult cardiac surgery in France.
Patients over the age of 65 most often receive a bioprosthetic aortic valve during an isolated aortic valve replacement or in combination with another cardiac surgery, which may extend the operative time.
The Perceval bioprosthesis has the advantage to reduce operative time due to its automatic deployment on a stent, which shortens the suturing time compared to other bioprostheses that require more sutures (sutureless valve).
In this retrospective, single-center, observational descriptive study, the investigators are conducting a follow-up of 193 patients operated on at the Montpellier University Hospital between January 2012 and January 2023, who received a Perceval aortic valve as part of routine annual follow-up, in order to assess the durability of this valve based on clinical and echocardiographic Valve Academic Research Consortium 3 (VARC-3) criteria.
Detailed description
Exclusion Criteria :
Perceval bioprosthesis explanted during the same surgical procedure. History of aortic root surgery.
Primary Endpoint :
- Survival free from valve degeneration, according to VARC-3 criteria for structural or non-structural valve dysfunction.
Secondary endpoints :
- Freedom from aortic valve reintervention
- Freedom from SVD
- Freedom from permanent pacemaker implantation
- Freedom from stroke or transient ischemic attack
- Freedom from cardiac related rehospitalization
- Cardiac-specific mortality
Preoperative clinical data are collected via the DxCare electronic medical record system (including weight, height, medical history, and cardiovascular risk factors). Surgical data (type of procedure, operative time, outcomes at the end of surgery) are also extracted from the same software.
Follow-up Procedures :
Included patients are systematically scheduled for a cardiology follow-up consultation as part of routine annual postoperative care at the university hospital or in private practice. During this visit, they undergo a transthoracic echocardiography and a clinical assessment of their health status. These data are collected for analysis.
If patients are not followed up at the hospital and are considered lost to follow-up, their referring cardiologist will be contacted to obtain the most recent cardiological health data.
The annual follow-up echocardiography focuses on evaluating the hemodynamic parameters and durability of the bioprosthesis (presence or absence of pathological regurgitation, leaflet immobility, or thickening).
Clinical status is also assessed during the annual follow-up, including symptoms such as dyspnea, chest pain, and limitations in daily activities.
As part of standard follow-up, patients are contacted by phone and informed of the purpose of their scheduled visit to the Montpellier University Hospital.
For patients unable to attend an in-person consultation, a telephone interview is conducted to assess their clinical status, and their cardiologist is contacted to provide the most recent echocardiography report and clinical follow-up data. For patients who died before the beginning of the study, their trusted contact is approached to obtain clinical information regarding their medical history prior to death.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe or non-severe aortic disease, symptomatic or asymptomatic, who received a rapidly deployed Perceval aortic bioprosthesis between January 1, 2012, and January 31, 2023, in the cardiac surgery department at Montpellier University Hospital.
Key inclusion criteria (1 listed)
- Patients with severe or non-severe aortic stenosis, symptomatic or asymptomatic, who received a rapidly deployed Perceval aortic bioprosthesis between January 1, 2012, and January 31, 2023, in the cardiac surgery department at Montpellier University Hospital.
Key exclusion criteria (2 listed)
- Perceval bioprosthesis explanted during the same surgical procedure.
- History of aortic root surgery.
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
survival without Bioprosthetic Valve Failure
Time frame: From enrollment to the last news (up to 130 months) or death
6 secondary outcomes
Survival without reoperation
Time frame: From enrollment to the last news (up to 130 months) or death
Survival without structural valve deterioration
Time frame: From enrollment to the last news (up to 130 months) or death
survival without pacemaker implantation
Time frame: From enrollment to the last news (up to 130 months) or death
survival without stroke
Time frame: From enrollment to the last news (up to 130 months) or death
Survival without rehospitalization for cardiac origin
Time frame: From enrollment to the last news (up to 130 months) or death
Survival without death for cardiac origin
Time frame: From enrollment to the last news (up to 130 months) or death
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 11 Aug 2025.
- Background31. Fischlein T, Meuris B, Hakim-Meibodi K, Misfeld M, Carrel T, Zembala M, et al. The sutureless aortic valve at 1 year: A large multicenter cohort study. JTCVS. (2016) ; 151(6):1617-1626.e4. 32. Fischlein T, Meuris B, Folliguet T, Hakim-Meibodi K, Misfeld M, Carrel T, et al. Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study. JTCVS. (2022) ; 164(6):1772-1780.e11. 35. Généreux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, et al. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. JACC. (2021) ; 77(21):2717-46.
- Individual participant dataSharing planned: No
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Not yet recruiting
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stenoses, Aortic Valve and Aortic Insufficiency, run by University Hospital, Montpellier.
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 1 inclusion and 2 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
survival without Bioprosthetic Valve Failure (time frame: From enrollment to the last news (up to 130 months) or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07116265, which also lists 1 linked publication.
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 11 Aug 2025.