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

NCT07366671 | Recruiting

• 2 other identifiers: SAPPHIRE - nWMO-2025.152Funder
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TAVI(Transcatheter Aortic Valve Implantation); Aortic Valve Disease

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• dr Pim A.L. Tonino: lead
• Haemonetics Corporation: collaborator

Study Sites (1)

Catharina Hospital Eindhoven

Eindhoven, North Brabant, 5623EJ, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Pim A.L. Tonino, MD, PhD

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 26, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

NL (1)