SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation (SAPPHIRE)

dr Pim A.L. Tonino

Status: Not yet enrolling

Conditions: Aortic Valve Disease; TAVI(Transcatheter Aortic Valve Implantation)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07366671

SAPPHIRE - nWMO-2025.152

Funder (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this observational study is to document which LV-guidewires are used during a TAVI (Transcatheter Aortic Valve Implantation) procedure and how their different functions perform.

A TAVI procedure is a minimally invasive treatment for aortic stenosis, where a new heart valve is inserted through a blood vessel in the groin. During this procedure, a wire (specifically, an LV-guidewire) is used to place the new heart valve. For this purpose, a regular LV-guidewire or a newer LV-guidewire with extra features, the Savvywire, can be used. All of these wires work well, are safe, and are already used in daily medical practice. Researchers will compare these LV-guidewires to see if the Savvywire adds additional value.

Patients aged 50 or older who undergo a TAVI procedure via the femoral artery (blood vessel in the groin) can participate. Participants will receive the usual care and standard follow-up, only their data will be collected and analyzed.

Full description

Patients are asked for consent after the TAVI procedure. Procedural data is therefore collected retrospectively, while standard follow-up data (3 months after the procedure) is collected prospectively.

Enrollment: 300 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 50 years
• Accepted for transfemoral TAVI procedure by Heart team and TAVI team
• Transfemoral TAVI procedure with balloon-expandable or self-expandable TAVI platform
• Ability to understand and the willingness to provide written informed consent
• Patients scheduled for valve-in-valve procedures can be included
• Patients with bicuspid anatomy can be included

Exclusion criteria

• Patients planned for a non-transfemoral TAVI procedure
• Extremely horizontal aorta (aortic root angle >70 degrees)
• Extreme tortuosity at the level of the iliofemoral arteries, abdominal and/or thoracic aorta
• Inability to provide informed consent.

Trial design

300 participants in 2 patient groups

SavvyWire

Description:

TAVI procedures in which the SavvyWire is used as LV-guidewire.

Other LV-guidwire

Description:

TAVI procedures in which another LV-guidewire (i.e. Confida or Safari) is used.