Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Conditions
Keywords
TAVI, Transcatheter Aortic Valve Implantation, Evolut FX+, Aortic Stenosis, Cusp Overlap Technique, Conduction Disorders, Evolut FX+ TAVI System, TAVI System
Brief summary
The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement. The main questions it aims to answer are: * Can using a standardized procedure for the impantation of the Medtronic Evolut™ FX+ TAVI System increase safety and efficiency? * What are the short-term (30 days) and long-term (1 year) patient outcomes, including the need for a pacemaker, complications, and valve function? Participants will undergo TAVI with the Medtronic Evolut™ FX+ TAVI System as part of their routine care. Be followed during their hospital stay, at 30 days, and at 1 year to check heart health, valve function, and recovery. 500 people at 12 hospitals in Portugal will take part in this registry.
Interventions
None listed
Sponsors
Portuguese Association of Interventional Cardiology
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects more than 18 years old, able to provide an Informed Consent: * Severe symptomatic (defined as New York Heart Association (NYHA) class ≥ II) aortic stenosis (AS), including but not limited to: Dyspnea at rest or on exertion, fatigue, angina, syncope in the absence of another identifiable cause; * Subjects provided written Informed Consent as approved by the Ethics Committee (EC);
Exclusion criteria
* Subjects with pre-existing surgical bioprosthetic aortic valve; * Hepatic insufficiency (Child-Pugh Class B or C); * Contraindicated for treatment with the Medtronic Evolut™ FX+ TAVU System in accordance with the Instructions for Use (IFU); * Anatomically considered not suitable for the Medtronic Evolut™ FX+ TAVI system; * Subjects are currently participating in another clinical investigation that may confound the results of this Registry; * Subjects have an expected survival less than one year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VARC-3 technical success | Immediately after the index procedure | A composite outcome assessed immediately after the TAVI procedure, including: survival, successful vascular access and device deployment/retrieval, correct positioning of a single valve, and freedom from major complications or need for surgery/intervention (excluding pacemaker). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Permanent Pacemaker Implantation (PPI) | 30 days after procedure | Percentage of participants who require a new permanent pacemaker due to new or worsening conduction disturbances. |
| Length of Hospital Stay | Up to 30 days after procedure | Number of days from TAVI procedure to discharge. |
| All-Cause Mortality | 30 days and 1 year | Death from any cause. |
| Stroke | 30 days and 1 year | Any new neurologic deficit classified as a stroke by clinical evaluation. |
| Life-Threatening Bleeding | 30 days and 1 year | Severe bleeding events defined by VARC-3 criteria. |
| Acute Kidney Injury | 30 days and 1 year | Kidney dysfunction as defined by VARC-3 criteria. |
| Coronary Artery Obstruction | 30 days and 1 year | Blockage requiring clinical intervention. |
| Major Vascular Complications | 30 days and 1 year | Serious vascular complications as defined by VARC-3 criteria |
| Valve Dysfunction Requiring Reintervention | 30 days and 1 year | Prosthetic valve dysfunction that requires repeat procedure. |
| Rehospitalization | 30 days and 1 year | Rehospitalization for valve-related symptoms or worsening heart failure. |
| Prosthetic Valve Function | 30 days and 1 year | Echocardiographic measures of valve function: left ventricular ejection fraction, peak velocity, mean gradient, effective orifice area, indexed effective orifice area, and prosthetic aortic valve regurgitation. It is defined as YES if: peak velocity is \< 3 m/s AND mean gradient \< 20 mmHg AND DVI \> 0,25\* AND Regurgitation \< moderate (this means that LV and index EOA are indirectly in it, no cutt offs are needed) \* DVI is the ratio of the Velocity-Time Integral (VTI) in the Left Ventricular Outflow Tract (LVOT) to the VTI across the stenotic aortic valve. It is measured based on the peak velocity /Grad, Effective orifice area (cm²) |
Countries
Portugal
Contacts
CONTACTRui C Teles, MD, PhD
CONTACTJoana D Silva, MD, PhD
PRINCIPAL_INVESTIGATORRui C Teles, MD, PhD
Hospital de Santa Cruz - Unidade Local de Saúde de Lisboa Ocidental
Outcome results
None listed