NCT07366671: SAPPHIRE

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

Recruiting now Last updated 10 March 2026

What this trial tests

trial in TAVI(Transcatheter Aortic Valve Implantation) in 300 participants. Currently enrolling.

Timeline

12 January 2026

Primary endpoint
1 December 2027

1 March 2028

Quick facts

Lead sponsor	dr Pim A.L. Tonino
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	300
Start date	12 January 2026
Primary completion	1 December 2027
Estimated completion	1 March 2028
Sites	1 location across Netherlands

Conditions studied

• TAVI(Transcatheter Aortic Valve Implantation) — all drugs for TAVI(Transcatheter Aortic Valve Implantation) →
• Aortic Valve Disease — all drugs for Aortic Valve Disease →

Sponsor

dr Pim A.L. Tonino

Who can join

50 and older, any sex, with TAVI(Transcatheter Aortic Valve Implantation) or Aortic Valve Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).
• 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 postdil
• 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
  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)
• 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.
• Pacing performance of the SavvyWire
  Time frame: At enrollment
  Based on: pacing frequency, loss-of-capture, the need for RV pacing

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.