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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
Sponsordr Pim A.L. Tonino

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • Not listed

Trial groups

300 Participants
are grouped into 2 trial groups

Sponsors and collaborators

dr Pim A.L. Tonino

Lead sponsor

Catharina Ziekenhuis Eindhoven

Sponsor institution

Haemonetics Corporation

Collaborator