Noninvasive comparison of cardiac output before and after transcatheter aortic valve implantation (TAVI) using HemoSphere® monitoring

Noninvasive comparison of cardiac output before and after transcatheter aortic valve implantation (TAVI) using HemoSphere® monitoring - Hemosphere_TAVI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038227

Enrollment

Registered

2025-10-28

Start date

2025-11-07

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

I35.0

Interventions

Group 1: Invasive haemodynamic monitoring using continuous, invasive arterial blood pressure measurement and non-invasive, continuous haemodynamic monitoring using the HemoSphere® system.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing TAVI. Use of arterial catheter and non-calibrated pulse wave analysis (HemoSphere).

Exclusion criteria

Exclusion criteria: No use of arterial catheters and non-calibrated pulse waveform analysis (HemoSphere)

Design outcomes

Primary

Measure	Time frame
Recording of immediate hemodynamic changes in cardiac output (CO) before and after transcatheter aortic valve implantation (TAVI) using continuous invasive or established noninvasive methods. Quantification of the difference in CO values before versus after TAVI to prospectively characterize the acute hemodynamic effect of the procedure.	—

Secondary

Measure	Time frame
Comparison of blood pressure measurement using uncalibrated pulse waveform analysis (HemoSphere, Edwards Lifesciences) with invasive arterial reference (art. catheter) in terms of accuracy, precision, and trend display.	—

Countries

Germany

Contacts

Public ContactFlorian Piekarski

Universitätsklinikum Bonn Klinik für Anästhesiologie und Operative Intensivmedizin

florian.piekarski@ukbonn.de+491713150966

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026