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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The goal of this registry is to learn how the Medtronic Evolutâ„¢ 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:
Participants will undergo TAVI with the Medtronic Evolutâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with severe aortic stenosis undergoing Medtronic Evolut FX+ TAVI System | Subjects with severe, symptomatic aortic stenosis (AS) with indication for TAVI (Transcatheter Aortic Valve Implant) with the Medtronic Evolutâ„¢ FX+ TAVI System - registry of routine practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| VARC-3 technical success | 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). | Immediately after the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Permanent Pacemaker Implantation (PPI) | Percentage of participants who require a new permanent pacemaker due to new or worsening conduction disturbances. | 30 days after procedure |
| Length of Hospital Stay |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Technique Compliance (TAVI.PTrainer Survey) | Assessment of operator adherence to standardized TAVI procedural steps, including Cusp Overlap Technique, using a dedicated checklist tool. | During the index procedure |
| Correlation of Procedural Compliance with Clinical Outcomes |
Inclusion Criteria:
Exclusion Criteria:
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The study population includes patients with severe, symptomatic AS with indication for TAVI, who meet the criteria for use of the Medtronic EvolutTM FX+ System in accordance with IFU and local regulations.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui C Teles, MD, PhD | Contact | (+351) 210 433 069 | rcteles@outlook.com | |
| Joana D Silva, MD, PhD | Contact | secretariado.apic@spc.pt |
| Name | Affiliation | Role |
|---|---|---|
| Rui C Teles, MD, PhD | Hospital de Santa Cruz - Unidade Local de Saúde de Lisboa Ocidental | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospitais da Universidade de Coimbra | Recruiting | Coimbra | Coimbra District | 3004-561 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20961243 | Background | Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22. | |
| 24678937 |
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Number of days from TAVI procedure to discharge.
| Up to 30 days after procedure |
| All-Cause Mortality | Death from any cause. | 30 days and 1 year |
| Stroke | Any new neurologic deficit classified as a stroke by clinical evaluation. | 30 days and 1 year |
| Life-Threatening Bleeding | Severe bleeding events defined by VARC-3 criteria. | 30 days and 1 year |
| Acute Kidney Injury | Kidney dysfunction as defined by VARC-3 criteria. | 30 days and 1 year |
| Coronary Artery Obstruction | Blockage requiring clinical intervention. | 30 days and 1 year |
| Major Vascular Complications | Serious vascular complications as defined by VARC-3 criteria | 30 days and 1 year |
| Valve Dysfunction Requiring Reintervention | Prosthetic valve dysfunction that requires repeat procedure. | 30 days and 1 year |
| Rehospitalization | Rehospitalization for valve-related symptoms or worsening heart failure. | 30 days and 1 year |
| Prosthetic Valve Function | 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) | 30 days and 1 year |
Analysis of whether higher compliance with optimized TAVI procedural steps is associated with better patient outcomes. |
| Procedure through 1 year |
| Hospital da Luz Coimbra | Not yet recruiting | Coimbra | Coimbra District | 3020-479 | Portugal |
|
| Hospital CUF Tejo | Recruiting | Lisbon | Lisbon District | 1350-352 | Portugal |
|
| Hospital de Santa Cruz | Recruiting | Lisbon | Lisbon District | 1449-005 | Portugal |
|
| Hospital LusÃadas Lisboa | Not yet recruiting | Lisbon | Lisbon District | 1500-458 | Portugal |
|
| Hospital da Luz Lisboa | Not yet recruiting | Lisbon | Lisbon District | 1500-650 | Portugal |
|
| Hospital Santa Maria | Recruiting | Lisbon | Lisbon District | 1649-035 | Portugal |
|
| Hospital Santa Marta | Recruiting | Lisbon | Lisbon District | 2855-697 | Portugal |
|
| Hospital Dr. Nélio Mendonça | Not yet recruiting | Funchal | Madeira | 9004-514 | Portugal |
|
| Hospital Universitário de São João | Recruiting | Porto | Porto District | 4200-319 | Portugal |
|
| Hospital Eduardo Santos Silva | Not yet recruiting | Vila Nova de Gaia | Vila Nova de Gaia | 4434-502 | Portugal |
|
| Hospital do EspÃrito Santo de Évora | Not yet recruiting | Evora | Évora District | 7000-811 | Portugal |
|
| Background |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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