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Completed

NCT Number: NCT05492383

SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)

The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.

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Key information

Conditions

Severe Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Germans Trias i Pujol, Badalona, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is at least 18 years old
  • Subject has a severe symptomatic AS undergoing a TAVI procedure
  • Subject with a THV for which rapid pacing is considered necessary during valve implantation
  • Subject agrees to participate in the study and is able to sign the informed consent form

Exclusion criteria

  • Failure to provide signed informed consent
  • Extremely horizontal aorta (aortic root angle ≥70°)
  • Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta
  • Inability to receive full anticoagulation during the TAVI procedure
  • Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life-threatening complication.

Treatment and study plan

TAVI

Device

Patients with severe symptomatic AS undergoing Transcatheter aortic valve implantation (TAVI)

Primary outcomes

  1. Percentage of patients with effective rapid pacing run

    Time frame: during surgery

    Effective rapid pacing will be defined as an adequate ventricular pacing capture by the SavvyWireTM leading to a reduction of systolic aortic pressure value <60 mmHg.

Secondary outcomes

  1. Presence of major complications (safety)

    Time frame: during surgery

    Presence of major complications related to the SAVVY guidewire including guidewire kink hindering or preventing the advancement of the transcatheter valve system, left ventricular perforation and pacing capture translating into major clinical consequences (transcatheter valve malpositioning or embolization).

  2. Percentage of patients with hemodynamic assessment without additional manipulation (pressure efficacy)

    Time frame: during surgery

    Ventricular pressure recording with the SavvyWireTM, allowing gradient calculation and display by the OptoMonitor 3, without the need of additional device exchanges through the aortic valve after valve implantation.

  3. Percentage of patient with valve advancement to intended position (mechanical efficacy)

    Time frame: during surgery

    Effective advancement of the THV delivery system over the SavvyWireTM allowing a precise positioning of the valve to the intended deployment position.

Sponsors and collaborators

Lead sponsor

Opsens, Inc.

Industry

Registry information

Acronym: SAFE-TAVI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2022
Registry last updated
Apr 12, 2023

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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