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Recruiting NCT07366671

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

— Observational TAVI(Transcatheter Aortic Valve Implantation) Aortic Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: TAVI(Transcatheter Aortic Valve Implantation), Aortic Valve Disease. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Detailed 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.

Primary outcome measures

  • Register which TAVI LV-guidewires are used in contemporary practice [Time frame: At enrollment]
  • To register LV-aortic pressure gradients (mmHg) during each procedural step in the SavvyWire group. [Time frame: Collected during TAVI procedure, extracted at enrollment]
  • To correlate hemodynamic pressure gradient after each procedural step (predilatation, 80% TAVI deployment, postdilatation) to standard baseline CT assessment of valvular calcifications [Time frame: At enrollment]
  • Performance of the SavvyWire as LV-guidewire for TAVI device placement [Time frame: At enrollment + after 3 months of standard follow-up]
  • Performance of the SavvyWire in hemodynamic guidance [Time frame: At enrollment]
  • Pacing performance of the SavvyWire [Time frame: At enrollment]
  • To investigate the potential streamlining effect of the SavvyWire on TAVI workflow [Time frame: At enrollment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Catharina Hospital Eindhoven — Eindhoven

Identifiers

NCT: NCT07366671 · SAPPHIRE - nWMO-2025.152 · Funder

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗