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Not yet recruiting NCT07539909

Alternative Peripheral TAVI Accesses

Observational Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TAVI procedures with an alternative access.
Who it may be relevant to
Registry conditions: Aortic Stenosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The APTA (Alternative Peripheral TAVI Accesses) Registry.

Overview

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.

Interventions

  • Procedure TAVI procedures with an alternative access
    Transcatheter aortic valve implantation via the common carotid artery and the subclavian or axillary artery

Primary outcome measures

  • 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 )]
Secondary outcome measures (1)
  • Secondary Outcome [Time frame: at 30-days and at 1-year after TAVI procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07539909 · 01DH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗