Alternative Peripheral TAVI Accesses
ConditionAortic Stenosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedical University of Silesia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or females qualified by the "heart team" for TAVI procedure, without the possibility of using femoral access.
Possibility of TAVI procedure with peripheral access after multi-slice computed tomography analysis.
Disqualifiers
No significant aortic stenosis
Cancer with a short expected survival period
No qualifications for TAVI
Trial population
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).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
TAVI procedures with an alternative access
Procedure/SurgeryTranscatheter aortic valve implantation via the common carotid artery and the subclavian or axillary artery
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Non-femoral TAVI1 intervention
Trial outcomes
Primary outcomes
1
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 outcomes
1
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 procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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