Prosthesis SurvivalTAVISARNCT05261204
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
An observational study of Prosthesis Survival and Prosthesis; Cardiac, Heart, Functional Disturbance as Result, run by Centre Cardiologique du Nord at 1 site in France.
Trial summary
The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
- What is being tested?
- Transcatheter Aortic Valve Implantation, Bioprothesis and Sutureless
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2013to 31 May 2029
- Phase
- Observational
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Adults with aortic valve stenosis with or without CAD who were symptomatic of congestive heart failure and unresponsive to medical therapy and who were eligible for mechanical intervention performed with the use of TAVI procedure or surgical aortic valve replacement. The severity of AVS was assessed by transthoracic echocardiography, performed using the European Society of Echocardiography criteria.
Who may be able to join
- Individuals enrolled in TAVI arm were required to have the predicted risk of operative mortality was ≥ 15% and/or a STS score of ≥ 10. A candidate who did not meet the STS score criteria of ≥ 10 was included in the study if a peer review by at least two surgeon investigators concluded and documented that the patient's predicted risk of operative mortality was ≥ 15%. For all group Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient > 40 mm Hg or jet velocity > 4.0 m/s or an aortic valve area (AVA) of < 0.8 cm2 (or AVA index < 0.5 cm2/m2).
Who cannot join
- • Patients with evidence of an acute myocardial infarction ≤ 1 month before the intended treatment (defined as Q wave MI, or non-Q wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin level elevation.
- Blood dyscrasias as defined : leukopenia (WBC < 3000 mm3), acute anemia (Hb < 9 mg%), thrombocytopenia (platelet count < 50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
- Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
- Need for emergency surgery for any reason.
- Hypertrophic cardiomyopathy with or without obstruction.
- Severe ventricular dysfunction with LVEF < 20%.
Show all 21Show fewer
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel
- (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated.
- For TAVI arm Native aortic annulus size < 18mm or 25mm as measured by echocardiogram.
- Subject was offered surgery but refused surgery.
- Recent (within 6 months) cerebrovascular accident or transient ischemic attack.
- Renal insufficiency (creatinine > 3.0mg/dL) and/or end stage renal disease requiring chronic
- dialysis.
- Life expectancy < 12 months due to non-cardiac co-morbid conditions.
- For TAVI group significant abdominal or thoracic aorta disease, including aneurysm (defined as maximal luminal diameter 5 cm or greater), marked tortuosity, aortic arch atheroma, narrowing of the abdominal aorta with particular regard for calcification and surface irregularities, or severe "unfolding" and tortuosity of the thoracic aorta. This criteria were applicable for transfemoral patients only.
- For TAVI group Iliofemoral vessel characteristics that would preclude safe placement of 14F or 18F introducer
- For TAVI arm sheath such as severe calcification, severe tortuosity or vessels size diameter < 7 mm for 22F
- Active bacterial endocarditis or other active infections.
- For TAVI arm bulky calcified aortic valve leaflets in close proximity to coronary ostia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Operation for Aortic-Valve Stenosis in Patients at Risk to Severe Valve Obstruction.
The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI). The key question of this study is to establish the difference in all-cause and cause-specific (cardiac vs noncardiac) mortality, all hospitalizations for heart failure within 24 months of follow-up, left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-diastolic volume (LVEDV), in patients who received the TAVI vs the standard surgical procedure for AVS. Any potential failure of the devices in question will be thoroughly investigated by means of CT scanning and biomechanical computational modelling, utilising finite element analysis (FEA).
Read the detailed description
The target population enrolled in the study includes patients with aortic-valve stenosis at risk to severe valve obstruction who have had TAVI or standard surgical procedure of their aortic valve with or without coronary artery by pass grafting (CABG) or percutaneous coronary intervention (PCI). Individuals were adequately treated per applicable standards, including for coronary artery disease (CAD), left ventricular (LV) dysfunction, AVS, and heart failure (HF). Patients enrolled in the studies were New York Heart Association (NYHA) functional class II, III, or outpatient NYHA IV.
Three groups of patients are included in the study. Patients who were managed with TAVI, patients who received AVR with conventional stented xenograft and recipients of AVR undergoing surgery with the use of sutureless aortic valve.
we calculated that a total of 649 patients per group would be needed for 90% power to show an absolute between-groups difference of 10% in the primary outcome at a two-sided alpha level of 0.02 (corrected alpha level to take into account multiple comparison between 3 groups). In this exhaustive study between 2011 and 2021, we hope to include a total of 6700 patients (2800 in the TAVI group, 3200 patients who received AVR with conventional stented xenograft and 700 patients with the use of sutureless aortic valve).
Two supplementary studies will be conducted. The study will concentrate on the CT scan evaluation of potential morphological and functional alterations in the aortic root following implantation of the respective devices, incorporating a comparative analysis. The second study will concentrate on the biomechanics of the implanted device and potential failure, using a finite element analysis investigation.
- Being tested
- Transcatheter Aortic Valve Implantation, Bioprothesis, Sutureless
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ImplantationDevice
Also called Transcatheter Aortic Valve Repacement
Patients who are deemed receive TAVI first underwent evaluation of their peripheral arteries before the procedure, in order to separate those eligible for transfemoral placement (TFP) from those who would require transapical placement. Technological advances achieved in the new platforms for the treatment of SHD have allowed the use of reduced size catheters and sheaths in the new armamentarium, favoring the TFP technique. The transcatheter valve (TV) is positioned at the level of the native aortic valve during the final step of valve replacement, when the balloon is inflated within the native valve during a brief period of rapid ventricular pacing. The delivery system i traverses the aorta retrograde over a guidewire from its point of insertion in the femoral artery during the use of TFP. Before balloon inflation, the valve and balloon are collapsed on the catheter and fit within the sheath. After balloon inflation, the calcified native valve is replaced by the expanded TV
BioprothesisProcedure or surgery
Also called SAVR
The bioprosthesis is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use.
SuturelessProcedure or surgery
Also called SAVR
The sutureless is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Implantation | Patients with aortic-valve stenosis at risk to severe valve obstruction who received TAVI with or without CABG or PCI. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, aortic valve stenosis, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV. Receives: Device: Transcatheter Aortic Valve Implantation; Procedure: Bioprothesis; Procedure: Sutureless | |
| Bioprosthesis | Patients with aortic-valve stenosis at risk to severe valve obstruction who undervent SAVR with the use of bioprosthesis with or without CABG or PCI. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, aortic valve stenosis, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV. Receives: Device: Transcatheter Aortic Valve Implantation; Procedure: Bioprothesis; Procedure: Sutureless | |
| Sutureless | Patients with aortic-valve stenosis at risk to severe valve obstruction who were managed by mean of SAVR with the use of sutureless with or without CABG or PCI. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, aortic valve stenosis, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV. Receives: Device: Transcatheter Aortic Valve Implantation; Procedure: Bioprothesis; Procedure: Sutureless |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation
Measured: 5 years
Hospitalizations for Heart Failure (HF)
The secondary endpoint of the study is the evaluation of hospedalization rates for heart failure valve due to structural/ non structural valve deterioration, thromboembolism and recurrent endocarditis
Measured: 5 yeras
Determining Device Malfunction Through CT Evaluation of the Aortic Root
The primary endpoint of the study is the degree of device failure, assessed by measuring the aortic root via CT scan
Measured: 5 years
Predictive Determination of Device Malfunction Through FEA of the Aortic Root
The primary objective of the study is to assess the degree of device malfunction. This is achieved by measuring the mechanical characteristics of the aortic root using computational modelling. The modelling compares different implanted devices.
Measured: 5 years
Secondary outcomes (7)
Overall Mortality
The secondary endpoint of the study is the evaluation of overall mortality
Measured: 5 years
Cardiac Death
The secondary endpoint of the study is the evaluation of cardiac death
Measured: 5 years
Non Cardiac Death
The secondary endpoint of the study is the evaluation of non cardiac death
Measured: 5 years
Major Adverse Cardiac or Cerebrovascular Events (MACCE)
Composite of major adverse cardiac or cerebrovascular events (rate of death, stroke, subsequent mitral valve surgery, hospitalization for heart failure, or an increase in New York Heart Association class higher than one), serious adverse events, recurrent aortic regurgitation, quality of life, and rehospitalization
Measured: 5 years
Echocardiographic Parameter Changes (LVEF)
Changes from baseline parameters including left ventricular ejection fraction
Measured: 5 years
Echocardiographic Parameter Changes ( AVR recurrence)
Recurrent moderate-to-severe aortic regurgitation after intervention
Measured: 5 years
Echocardiographic Parameter Changes (LVEDD/LVEDV)
Changes from baseline Left Ventricular End Diastolic Diameter or Volume
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jan 2013
- Primary completion1 Dec 2026 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prosthesis SurvivalStudies 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Cardiologique du Nord
- Sponsor type
- University, hospital or other
- Collaborators
- Henri Mondor University Hospital, Universita degli Studi di Genova
- Responsible party
- Principal investigator, Francesco Nappi, Centre Cardiologique du Nord
- Investigators
- Francesco Nappi, Principal investigator, Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261204
- Sponsor's protocol ID
- CN-22-25
- Acronym
- TAVISAR
- Status last verified
- Jul 2026
- First submitted
- 19 Feb 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nappi F, Salsano A, Avtaar Singh SS, El-Dean Z, Fiore A, Spadaccio C. Study protocol for an international prospective non-randomized trial evaluating the long-term outcomes of sutureless aortic valve replacement versus stented aortic valve replacement for aortic-valve stenosis in patients at risk to severe valve obstruction: the SAVI-AVR trial. J Cardiothorac Surg. 2026 Apr 21;21(1):330. doi: 10.1186/s13019-026-04091-z.
PubMed 42015281Nappi F, Schoell T, Avtaar Singh SS, Nassif A, Ellouze O, Nejjari M, Digne F, Stratief V, Dreyfus J, Spadaccio C. Measuring Stress on a Third-Generation Balloon-Expandable Aortic Valve During Expansion. J Vis Exp. 2025 Jul 11;(221). doi: 10.3791/67455.
PubMed 40720424Nappi F, Bourgois C, Nenna A, Salsano A, Schoell T, El-Dean Z, Fiore A, Spadaccio C. Study protocol for an internahaational prospective non-randomised trial evaluating the long-term outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement for aortic-valve stenosis in patients at risk to severe valve obstruction: the TAVISAR trial. BMJ Open. 2025 May 24;15(5):e101417. doi: 10.1136/bmjopen-2025-101417.
PubMed 40413055
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Operation for Aortic-Valve Stenosis in Patients at Risk to Severe Valve Obstruction.
- ClinicalTrials.gov ID
- NCT05261204
- Acronym / sponsor ID
- TAVISAR / CN-22-25
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Centre Cardiologique du NordUniversity, hospital or other
- Collaborators
- Henri Mondor University Hospital, Universita degli Studi di Genova
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 2 Mar 2022 (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 mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI). The key question of this study is to establish the difference in all-cause and cause-specific (cardiac vs noncardiac) mortality, all hospitalizations for heart failure within 24 months of follow-up, left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-diastolic volume (LVEDV), in patients who received the TAVI vs the standard surgical procedure for AVS. Any potential failure of the devices in question will be thoroughly investigated by means of CT scanning and biomechanical computational modelling, utilising finite element analysis (FEA).
Detailed description
The target population enrolled in the study includes patients with aortic-valve stenosis at risk to severe valve obstruction who have had TAVI or standard surgical procedure of their aortic valve with or without coronary artery by pass grafting (CABG) or percutaneous coronary intervention (PCI). Individuals were adequately treated per applicable standards, including for coronary artery disease (CAD), left ventricular (LV) dysfunction, AVS, and heart failure (HF). Patients enrolled in the studies were New York Heart Association (NYHA) functional class II, III, or outpatient NYHA IV.
Three groups of patients are included in the study. Patients who were managed with TAVI, patients who received AVR with conventional stented xenograft and recipients of AVR undergoing surgery with the use of sutureless aortic valve.
we calculated that a total of 649 patients per group would be needed for 90% power to show an absolute between-groups difference of 10% in the primary outcome at a two-sided alpha level of 0.02 (corrected alpha level to take into account multiple comparison between 3 groups). In this exhaustive study between 2011 and 2021, we hope to include a total of 6700 patients (2800 in the TAVI group, 3200 patients who received AVR with conventional stented xenograft and 700 patients with the use of sutureless aortic valve).
Two supplementary studies will be conducted. The study will concentrate on the CT scan evaluation of potential morphological and functional alterations in the aortic root following implantation of the respective devices, incorporating a comparative analysis. The second study will concentrate on the biomechanics of the implanted device and potential failure, using a finite element analysis investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Implantation | – | Device: Transcatheter Aortic Valve Implantation, Procedure: Bioprothesis, Procedure: SuturelessPatients with aortic-valve stenosis at risk to severe valve obstruction who received TAVI with or without CABG or PCI. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, aortic valve stenosis, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV. |
| Bioprosthesis | – | Device: Transcatheter Aortic Valve Implantation, Procedure: Bioprothesis, Procedure: SuturelessPatients with aortic-valve stenosis at risk to severe valve obstruction who undervent SAVR with the use of bioprosthesis with or without CABG or PCI. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, aortic valve stenosis, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV. |
| Sutureless | – | Device: Transcatheter Aortic Valve Implantation, Procedure: Bioprothesis, Procedure: SuturelessPatients with aortic-valve stenosis at risk to severe valve obstruction who were managed by mean of SAVR with the use of sutureless with or without CABG or PCI. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, aortic valve stenosis, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults with aortic valve stenosis with or without CAD who were symptomatic of congestive heart failure and unresponsive to medical therapy and who were eligible for mechanical intervention performed with the use of TAVI procedure or surgical aortic valve replacement. The severity of AVS was assessed by transthoracic echocardiography, performed using the European Society of Echocardiography criteria.
Key inclusion criteria (1 listed)
- Individuals enrolled in TAVI arm were required to have the predicted risk of operative mortality was ≥ 15% and/or a STS score of ≥ 10. A candidate who did not meet the STS score criteria of ≥ 10 was included in the study if a peer review by at least two surgeon investigators concluded and documented that the patient's predicted risk of operative mortality was ≥ 15%. For all group Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient > 40 mm Hg or jet velocity > 4.0 m/s or an aortic valve area (AVA) of < 0.8 cm2 (or AVA index < 0.5 cm2/m2).
Key exclusion criteria (21 listed)
- • Patients with evidence of an acute myocardial infarction ≤ 1 month before the intended treatment (defined as Q wave MI, or non-Q wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin level elevation.
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 |
|---|---|---|
| Transcatheter Aortic Valve ImplantationAlso: Transcatheter Aortic Valve RepacementPatients who are deemed receive TAVI first underwent evaluation of their peripheral arteries before the procedure, in order to separate those eligible for transfemoral placement (TFP) from those who would require transapical placement. Technological advances achieved in the new platforms for the treatment of SHD have allowed the use of reduced size catheters and sheaths in the new armamentarium, favoring the TFP technique. The transcatheter valve (TV) is positioned at the level of the native aortic valve during the final step of valve replacement, when the balloon is inflated within the native valve during a brief period of rapid ventricular pacing. The delivery system i traverses the aorta retrograde over a guidewire from its point of insertion in the femoral artery during the use of TFP. Before balloon inflation, the valve and balloon are collapsed on the catheter and fit within the sheath. After balloon inflation, the calcified native valve is replaced by the expanded TV | Device | Bioprosthesis, Sutureless, Transcatheter Aortic Valve Implantation |
| BioprothesisAlso: SAVRThe bioprosthesis is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use. | Procedure or surgery | Bioprosthesis, Sutureless, Transcatheter Aortic Valve Implantation |
| SuturelessAlso: SAVRThe sutureless is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use. | Procedure or surgery | Bioprosthesis, Sutureless, Transcatheter Aortic Valve Implantation |
Primary outcome
Treatment failure
Time frame: 5 years
The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation
Hospitalizations for Heart Failure (HF)
Time frame: 5 yeras
The secondary endpoint of the study is the evaluation of hospedalization rates for heart failure valve due to structural/ non structural valve deterioration, thromboembolism and recurrent endocarditis
Determining Device Malfunction Through CT Evaluation of the Aortic Root
Time frame: 5 years
The primary endpoint of the study is the degree of device failure, assessed by measuring the aortic root via CT scan
Predictive Determination of Device Malfunction Through FEA of the Aortic Root
Time frame: 5 years
The primary objective of the study is to assess the degree of device malfunction. This is achieved by measuring the mechanical characteristics of the aortic root using computational modelling. The modelling compares different implanted devices.
7 secondary outcomes
Overall Mortality
Time frame: 5 years
Cardiac Death
Time frame: 5 years
Non Cardiac Death
Time frame: 5 years
Major Adverse Cardiac or Cerebrovascular Events (MACCE)
Time frame: 5 years
Echocardiographic Parameter Changes (LVEF)
Time frame: 5 years
Echocardiographic Parameter Changes ( AVR recurrence)
Time frame: 5 years
Echocardiographic Parameter Changes (LVEDD/LVEDV)
Time frame: 5 years
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 19 Aug 2026.
- Derived from this study: PubMed 42015281Nappi F, Salsano A, Avtaar Singh SS, El-Dean Z, Fiore A, Spadaccio C. Study protocol for an international prospective non-randomized trial evaluating the long-term outcomes of sutureless aortic valve replacement versus stented aortic valve replacement for aortic-valve stenosis in patients at risk to severe valve obstruction: the SAVI-AVR trial. J Cardiothorac Surg. 2026 Apr 21;21(1):330. doi: 10.1186/s13019-026-04091-z.
- Derived from this study: PubMed 40720424Nappi F, Schoell T, Avtaar Singh SS, Nassif A, Ellouze O, Nejjari M, Digne F, Stratief V, Dreyfus J, Spadaccio C. Measuring Stress on a Third-Generation Balloon-Expandable Aortic Valve During Expansion. J Vis Exp. 2025 Jul 11;(221). doi: 10.3791/67455.
- Derived from this study: PubMed 40413055Nappi F, Bourgois C, Nenna A, Salsano A, Schoell T, El-Dean Z, Fiore A, Spadaccio C. Study protocol for an internahaational prospective non-randomised trial evaluating the long-term outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement for aortic-valve stenosis in patients at risk to severe valve obstruction: the TAVISAR trial. BMJ Open. 2025 May 24;15(5):e101417. doi: 10.1136/bmjopen-2025-101417.
- 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. This study is not recruiting at the moment.
Francesco Nappi principal investigator
Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France
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 Prosthesis Survival and Prosthesis; Cardiac, Heart, Functional Disturbance as Result, run by Centre Cardiologique du Nord at 1 site in France.
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 21 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 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 France. 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?
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?
Treatment failure (time frame: 5 years). The study lists 4 primary outcomes in all. 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 NCT05261204, which also lists 3 linked publications.
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 19 Aug 2026.