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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Disease; TAVI(Transcatheter Aortic Valve Implantation)

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Netherlands
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623EJ
      • Recruiting
      • Catharina Hospital Eindhoven
      • Contact: Prof Tonino; Phone Number: 0031-(040)-239 7004; Email: pim.tonino@catharinaziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients eligible for participation in this registry are aged ≥50 years old presenting with symptomatic severe aortic valve stenosis and accepted for transfemoral TAVI procedure after consultation in the Heart team and TAVI team. A pre-procedural CT scan for TAVI sizing is required as standard of care. Both balloon-expandable and self-expandable TAVI platforms are allowed. Valve-in-valve procedures and procedures in bicuspid aortic valve anatomy can be included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Register which TAVI LV-guidewires are used in contemporary practice	Register which type of TAVI LV-guidewire is used during the TAVI procedure (SavvyWire, Safari, Confida etc).	At enrollment
To register LV-aortic pressure gradients (mmHg) during each procedural step in the SavvyWire group.	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.	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		At enrollment
Performance of the SavvyWire as LV-guidewire for TAVI device placement	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)	At enrollment + after 3 months of standard follow-up
Performance of the SavvyWire in hemodynamic guidance	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.	At enrollment
Pacing performance of the SavvyWire	Based on: pacing frequency, loss-of-capture, the need for RV pacing	At enrollment
To investigate the potential streamlining effect of the SavvyWire on TAVI workflow	Based on: skin-to-skin time, total contrast volume (mL), amount of radiation exposure (total DAP, total Air Kerma)	At enrollment

Collaborators and Investigators

• Sponsor: dr Pim A.L. Tonino
• Collaborators: Haemonetics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: SAPPHIRE - nWMO-2025.152; Funder (Other Grant/Funding Number: Haemonetics)