Aortic Stenosis, Aortic Valve Disease
Conditions
Keywords
Biological aortic valves, Mechanical aortic valves, Aortic conduits, Sutureless Aortic Valve
Brief summary
Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide. The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU). This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.
Detailed description
SURE-AVR objective is to collect post market safety and performance data collected along the procedure and the relevant follow-up with Sorin Group aortic valve devices in accordance with the IFU to further evidence the safety and efficacy in a post-approval environment. All current and future Sorin Group aortic valve devices that have obtained CE-mark or other local regulatory and/or commercial approvals may be included in the registry. During the duration of the registry,other aortic valve replacement products or current devices might receive modifications and might become commercial available. This registry allows extensions for the inclusion of new products. This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry following the local applicable regulations. The data collection shall be performed as per the local standard of care and without exposing the patient to any additional risk to the treatment (s)he would normally receive. The registry is an open-ended project: * Inclusions phase: open-ended * Follow-up phase: annually throughout 5 years (7 and 10 years are optional). The study shall be completed after the 10-year follow-up of the last patient.
Interventions
None listed
Sponsors
Corcym S.r.l
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients must provide written or oral informed consent to participate in the registry depending on the local regulations. * Patients having received a Sorin Group aortic valve device in accordance with the IFU
Exclusion criteria
NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite rate of valve related major adverse events (MAEs) | At 5 years follow-up | To evaluate the composite rate of site reported valve related MAE defined as death, stroke and/or re-intervention (involving surgery or any other invasive therapy) at 5 years follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural timings | Intra-operative and at 30 days (average) | Cross clamp time, intensive care unit and total length of hospital stay. |
| Clinical success | 30 days (average) | The clinical success defined as a successful valve implantation without MAE at hospital discharge. |
| Improvement of clinical status | Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. | The improvement of clinical status defined as an improvement of at least one scale of the New York Heart Association (NYHA) classification between pre-procedure and annually throughout the duration of the registry. |
| MAE during the duration of the registry | Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. | All site reported MAE rates during the duration of the registry. |
| Composite rate of valve related MAE | 4-year, and 7 and 10-year follow-up in selected centers only | The composite rate of site reported valve-related MAE annually through a 4-year follow-up, and 7 and 10-year follow-up in selected centers only. |
| Valve-related Serious Adverse Event (SAE) | Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. | Other site reported valve-related SAE such as, but not limited to, bleeding, thromboembolism, valve thrombosis, endocarditis, non structural dysfunction, structural valve deterioration annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. |
| Echocardiographic evaluation | Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. | Performance of the device in terms of hemodynamic behavior - Effective Orifice Area (cm²), Ejection Fraction (%),Mean Aortic Gradient (mmHg), Peak Aortic Gradient (mmHg), LV mass (g) - throughout the duration of the registry. |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, Singapore, Slovakia, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed