Outcomes of FIrst and possibility of REdo-TAVI with different transcatheter heart valves

Outcomes of FIrst and possibility of REdo-TAVI with different transcatheter heart valves - FIRE TAVI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031563

Enrollment

260

Registered

2023-03-27

Start date

2023-01-20

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aortic stenosis

Interventions

Group 1: Patients after TAVI: Patients after TAVI are evaluated regarding their procedural (e.g. mortality, VARC criteria) and long-term outcome (e.g. mortality, hospitalisations).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with aortic regurgitation or stenosis and performed TAVI (01.01.2018-30.09.2022)

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Combined safety endpoint of all-cause mortality, myocardial infarction, stroke, life-threatening bleeding requiring transfusion, acute kidney injury with need for dialysis, and relevant vascular complications (defined according to the VARC 3 criteria) at discharge from the index hospitalization.	—

Secondary

Measure	Time frame
Procedural outcome (up to discharge from index hospitalization): Cardiovascular mortality Echocardiography post-TAVI: moderate to severe aortic regurgitation, mean preassure gradient Need of a new pacemaker Complications according to Valve Academic Research Consortium (VARC) 3 criteria Neo skirt height as a risk factor for coronary obstruction in case of redo-TAVI Follow-up with regard to survival, hospitalisations and symptoms	—

Measure

Time frame

Procedural outcome (up to discharge from index hospitalization): Cardiovascular mortality Echocardiography post-TAVI: moderate to severe aortic regurgitation, mean preassure gradient Need of a new pacemaker Complications according to Valve Academic Research Consortium (VARC) 3 criteria Neo skirt height as a risk factor for coronary obstruction in case of redo-TAVI Follow-up with regard to survival, hospitalisations and symptoms

—

Countries

Germany

Contacts

Public ContactHenryk Dreger

Deutsches Herzzentrum der Charité

kardio-ccm-sekretariat@charite.de+49 30 450 513 142

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026