An observational study in Prosthesis Survival and Prosthesis; Cardiac, Heart, Functional Disturbance as Result, sponsored by Centre Cardiologique du Nord. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Centre Cardiologique du Nord · Observational
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).
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.
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 119 across 49 observational studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Centre Cardiologique du Nord is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Transcatheter Aortic Valve Implantation · Procedure: Bioprothesis · Procedure: Sutureless
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.
Device: Transcatheter Aortic Valve Implantation · Procedure: Bioprothesis · Procedure: 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.
Device: Transcatheter Aortic Valve Implantation · Procedure: Bioprothesis · Procedure: Sutureless
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
Also known as: Transcatheter Aortic Valve Repacement
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.
Also known as: 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.
Also known as: SAVR
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 5 years
Overall Mortality
The secondary endpoint of the study is the evaluation of overall mortality
Time frame: 5 years
Cardiac Death
The secondary endpoint of the study is the evaluation of cardiac death
Time frame: 5 years
Non Cardiac Death
The secondary endpoint of the study is the evaluation of non cardiac death
Time frame: 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
Time frame: 5 years
Echocardiographic Parameter Changes (LVEF)
Changes from baseline parameters including left ventricular ejection fraction
Time frame: 5 years
Echocardiographic Parameter Changes ( AVR recurrence)
Recurrent moderate-to-severe aortic regurgitation after intervention
Time frame: 5 years
Echocardiographic Parameter Changes (LVEDD/LVEDV)
Changes from baseline Left Ventricular End Diastolic Diameter or Volume
Time frame: 5 years
CT scan evaluation of the aortic root.
The predetermined outcome is the assessment of changes to the aortic root.
Time frame: 5 years
Finite Element Analysis Study
Changes in the Mechanical Properties of AR Following Device Implantation Using Computational Modeling
Time frame: 5 years
Plan to share: No
Started Jan 2013 (actual). Primary completion is estimated for Dec 2026, 167 months after the start.
Of 28 observational studies under Prosthesis Failure, half reached primary completion within 181 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 184. This study's planned 167 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Centre Cardiologique du Nord