Does the alignment of a replacement artificial heart valve in the same direction as the patient’s own heart valve affect outcomes in aortic valve implantation? A feasibility study

Technical feasibility of neo-commissural alignment in Transcatheter Aortic Valve Implantation (TAVI): an exploratory study in patients undergoing TAVI describing procedural outcomes and effect on coronary artery access

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16090439

Enrollment

Registered

2023-04-20

Start date

2022-07-07

Completion date

Unknown

Last updated

2025-01-28

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

Conditions

Aortic stenosis Circulatory System

Interventions

Traditionally aortic valve replacement for patients with severe symptomatic aortic stenosis was achieved with surgical removal and implantation of a new mechanical or tissue valve necessitating cardio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) as decided by the structural heart multi-disciplinary team (MDT)

Exclusion criteria

Exclusion criteria: 1. Lack of vascular access to permit TAVI 2. Transaxillary or transcaval vascular access 3. Patient unable to undergo required post-TAVI CT-scan 4. Patient unable to give informed consent 5. Aged 100 years old 6. Decreased renal function eGFR <30ml/min 7. Pregnancy

Design outcomes

Primary

Measure	Time frame
1. TAVI valve alignment compared to patient's own aortic valve measured using cardiac-CT focusing on calculating the optimum commissural alignment during surgery 2. Coronary access using standard diagnostic catheters measured using CT-fractional flow reserve before and after the TAVI procedure	—

Secondary

Measure	Time frame
Computational fluid dynamics assessment of aortic blood flow measured using CT-fractional flow reserve before and after the TAVI procedure	—

Countries

England, United Kingdom

Contacts

Public ContactDuncan Fatz

duncan.fatz@nhs.net+44 (0)1273 696955

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026