Aortic StenosisAPTANCT07539909
Alternative Peripheral TAVI Accesses
An observational study of Aortic Stenosis, run by Medical University of Silesia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- TAVI procedures with an alternative access
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 1 Jul 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- No significant aortic stenosis
- Cancer with a short expected survival period
- No qualifications for TAVI
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Stenosis
- Being tested
- TAVI procedures with an alternative access
- Keywords
- trancarotid-TAVI, transaxillary-TAVI, aortic stenosis, alternative accesses
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVI procedures with an alternative accessProcedure or surgery
Also called Transcarotid TAVI, Transaxillary TAVI
Transcatheter aortic valve implantation via the common carotid artery and the subclavian or axillary artery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: TAVI procedures with an alternative access |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: at 30-days and at 1-year after TAVI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damian Hudziak, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539909
- Sponsor's protocol ID
- 01DH
- Acronym
- APTA
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data necessary for statistical analysis describing the safety of TAVI procedures using alternative approaches in accordance with the VARC-3 guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The APTA (Alternative Peripheral TAVI Accesses) Registry.
- ClinicalTrials.gov ID
- NCT07539909
- Acronym / sponsor ID
- APTA / 01DH
- Conditions
- Aortic Stenosis
- Keywords
- trancarotid-TAVI, transaxillary-TAVI, aortic stenosis, alternative accesses
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-femoral TAVI | – | Procedure: TAVI procedures with an alternative accesshigh 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- No significant aortic stenosis
- Cancer with a short expected survival period
- No qualifications for TAVI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVI procedures with an alternative accessAlso: Transcarotid TAVI, Transaxillary TAVITranscatheter aortic valve implantation via the common carotid artery and the subclavian or axillary artery | Procedure or surgery | Non-femoral TAVI |
Primary outcome
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.
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 )
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
1 secondary outcome
Secondary Outcome
Time frame: at 30-days and at 1-year after TAVI procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. Data necessary for statistical analysis describing the safety of TAVI procedures using alternative approaches in accordance with the VARC-3 guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Medical University of Silesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damian Hudziak MD PhD, MD PhD (0048 323598644, damhud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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 )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.