Alternative Peripheral TAVI Accesses

NCT07539909 | Not Yet Recruiting

• 1 other identifier: 01DH
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Aortic Stenosis

Keywords

trancarotid-TAVI; transaxillary-TAVI; aortic stenosis; alternative accesses

Outcome Measures

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

  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

  at 30-days and at 1-year after TAVI procedure

Study Arms (1)

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

Interventions

TAVI procedures with an alternative access PROCEDURE

Transcatheter aortic valve implantation via the common carotid artery and the subclavian or axillary artery

Also known as: Transcarotid TAVI, Transaxillary TAVI

Non-femoral TAVI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Silesia: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Damian Hudziak MD PhD, MD PhD

CONTACT

0048 323598644; damhud@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Deputy Head of the Cardiac Surgery Department

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 01.05.2026-01.07.2026
• Access Criteria: Statistical analysts and members of my team. Data will be transferred on data carriers (flash drives).