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NCT Number: NCT07366671

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

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.

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Key information

Conditions

TAVI(Transcatheter Aortic Valve Implantation) Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Register which TAVI LV-guidewires are used in contemporary practice

    Time frame: At enrollment

    Register which type of TAVI LV-guidewire is used during the TAVI procedure (SavvyWire, Safari, Confida etc).

  2. To register LV-aortic pressure gradients (mmHg) during each procedural step in the SavvyWire group.

    Time frame: Collected during TAVI procedure, extracted at enrollment

    With the SavvyWire, continuous hemodynamic pressure measurements can be performed during the procedure in the aorta and the left ventricle. Pressure measurements (mmHg) during the following procedural steps will be collected: baseline, pacing during predilatation, after predilatation, pacing during TAVI deployment, after TAVI deployment, after equilibration and drift check, after possibele postdilatation.

  3. 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

  4. Performance of the SavvyWire as LV-guidewire for TAVI device placement

    Time frame: At enrollment + after 3 months of standard follow-up

    Based on: guidewire kink yes/no, procedural success, complications during and after TAVI procedure and after standard 3 months follow-up (vascular complication, coronary obstruction, conversion to sternotomy, pacemaker, cva, mortality)

  5. Performance of the SavvyWire in hemodynamic guidance

    Time frame: At enrollment

    Based on: succesfull hemodynamic registrations, drift check (delta between aortic pressure measurement of Savvywire and standard pigtail in aorta used during TAVI procedure), more postdilatation in Savvywire group compared to regular LV guidewire group.

  6. Pacing performance of the SavvyWire

    Time frame: At enrollment

    Based on: pacing frequency, loss-of-capture, the need for RV pacing

  7. To investigate the potential streamlining effect of the SavvyWire on TAVI workflow

    Time frame: At enrollment

    Based on: skin-to-skin time, total contrast volume (mL), amount of radiation exposure (total DAP, total Air Kerma)

Sponsors and collaborators

Lead sponsor

dr Pim A.L. Tonino

Other

Collaborators

  • Haemonetics Corporation

Registry information

Official study title

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

Acronym: SAPPHIRE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 26, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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