Alternative Peripheral TAVI Accesses (APTA)

The APTA (Alternative Peripheral TAVI Accesses) Registry.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Procedure: TAVI procedures with an alternative access

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Damian Hudziak MD PhD, MD PhD; Phone Number: 0048 323598644; Email: damhud@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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).

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• No significant aortic stenosis
• Cancer with a short expected survival period
• No qualifications for TAVI

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-femoral TAVI; 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; Other Names: Transcarotid TAVI; Transaxillary TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Measures

Outcome Measure	Measure Description	Time Frame
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.	at 30-days and at 1-year after TAVI procedure

Collaborators and Investigators

• Sponsor: Medical University of Silesia

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: aortic stenosis; trancarotid-TAVI; transaxillary-TAVI; alternative accesses
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 01DH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data necessary for statistical analysis describing the safety of TAVI procedures using alternative approaches in accordance with the VARC-3 guidelines.
• IPD Sharing Time Frame: 01.05.2026-01.07.2026
• IPD Sharing Access Criteria: Statistical analysts and members of my team. Data will be transferred on data carriers (flash drives).
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No