Aortic Valve Replacement Clinical Trials

Clinical trials related to Aortic Valve Replacement Procedure

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation; a Prospective Registry (SAPPHIRE)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Catharina Hospital Eindhoven
RECRUITING
Eindhoven
Time Frame
Start Date: 2026-01-12
Estimated Completion Date: 2028-03
Participants
Target number of participants: 300
Treatments
SavvyWire
TAVI procedures in which the SavvyWire is used as LV-guidewire.
Other LV-guidwire
TAVI procedures in which another LV-guidewire (i.e. Confida or Safari) is used.
Sponsors
Leads: dr Pim A.L. Tonino
Collaborators: Haemonetics Corporation

This content was sourced from clinicaltrials.gov