Image

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

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

Recruiting
50 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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.

Study details
    TAVI(Transcatheter Aortic Valve Implantation)
    Aortic Valve Disease

NCT07366671

dr Pim A.L. Tonino

13 May 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.