An observational study in Aortic Stenosis, sponsored by Medical University of Silesia. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Medical University of Silesia · Observational
The APTA (Alternative Peripheral TAVI Accesses) registry is an observational multi-center, retrospective and prospective study, including high and medium - risk patients with aortic stenosis (AS) contraindicates for trans-femoral TAVI, treated with TAVI thought to peripheral accesses. Upper Silesian Medical Center, Katowice and the other hospitals will be involved in the study.
Consecutive patients who underwent TAVI with peripheral alternatives accesses between September 2017 and February 2025 will be enrolled for the retrospective registry, while consecutive patients from February 2025 will be enrolled for the prospective registry. Baseline clinical, angiographic, and echocardiographic variables, together with procedural and follow-up outcomes data will be recorded in a dedicated database.
According to the guidelines of international societies (European Society of Cardiology, European Association for Cardio-Thoracic Surgery, American College of Cardiology, and American Heart Association), trans- catheter aortic valve implantation (TAVI) using access through the femoral artery is a preferred treatment method in patients at high- and medium-risk patients with severe aortic stenosis. Due to peripheral arterial disease, unfavorable, aortoiliac anatomy, or diseases of the thoracoabdominal aorta, femoral access is unavailable for approximately 15% of all TAVI candidates. Alternative approaches in TAVI procedures can be divided into two groups: transthoracic (trans-aortic and trans-apical) and peripheral (trans-carotid, trans-axillary, trans-subclavian, trans-caval).
Exclusion Criteria:
high and medium - risk patients with aortic stenosis (AS) contraindicates for trans-femoral TAVI, treated with TAVI thought to peripheral accesses. Upper Silesian Medical Center, Katowice and the other hospitals will be involved in the study.
Procedure: TAVI procedures with an alternative access
Transcatheter aortic valve implantation via the common carotid artery and the subclavian or axillary artery
Also known as: Transcarotid TAVI, Transaxillary TAVI
Primary study endpoint will be according to VARC-3 criteria: Mortality Neurologic events, Hospitalization (or re-hospitalization), Bleeding and transfusions, Vascular and access-related complications, Cardiac and other procedural complications.
Preoperative data : Age (years), sex (male, female), weight (kg), height (m), BMI (kg/m2), EuroSCORE II (%), NYHA Class (New York Heart Assocation) Labolatory examinations: creatynine (mg/dl), GFR (glomerular filtration rate) ml/min/1,73m2, Troponine T level (ng/ml), Hemoglobin (g/dl), Hematocrit (%) Echocardiography (ECHO): LVEF: left ventricular ejection fraction (%), Pg max: aortic valve maximal gradient (mmHg), Pg mean: aortic valve mean gradient (mmHg), AVA: aortic valve area (cm2), Vmax: transaortic peak instantaneous velocity (m/s). Operative data: procedural success, technical aspect of TAVI procedural time, cerebral oximetry (%), vascular (acces) and cardiac complication. Postoperative data (more than 1 day after TAVI procedure to the day of discharge ), mortality, stroke, TIA (transient ischemic attack) , new onset atrial fibrillation, new pacemaker implantation, cardiac tamponade, psychosis, NYHA Class (New York Heart Assocation) Labolatory examinations as before TAVI
Time frame: Preoperative data (on the day of admission to hospital) Operative data ( day of TAVI procedure) Postoperative data (more than 1 day after TAVI procedure to the day of discharge )
Secondary Outcome
Secondary endpoints will include, according to the VARC-3 criteria: technical success of the device (correct measurements of flow velocity and gradients on echocardiogram and no paravalvular leaks) after 30 days, early safety after 30 days (mortality, neurological complications, rehospitalizations, no cardiac complications) and clinical efficacy (after one year). Analysis of parameters according to the criteria described above.
Time frame: at 30-days and at 1-year after TAVI procedure
No study locations are listed for this record.
Plan to share: Yes — Data necessary for statistical analysis describing the safety of TAVI procedures using alternative approaches in accordance with the VARC-3 guidelines.
Supporting information: Sap, Csr
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Medical University of Silesia