The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures

NCT05082337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-01-18

No results posted yet for this study

Summary

TAVR patients exhibiting post-procedural residual AR had higher mortality and hospitalization rates due to heart failure, with the extent of this association increasing proportionally to the severity of the regurgitation. Optimizing transcatheter valve performance by intra-procedural hemodynamic evaluation of AR and residual transvalvular gradient remains of high clinical importance.

Conditions

  • Aortic Valve Disease
  • Transcatheter Aortic Valve Replacement
  • Aortic Valve Stenosis
  • Hemodynamic Measurement

Interventions

DEVICE

SAVVY guidewire

The SAVVY guidewire will be used for rapid pacing runs, valve delivery and for left ventricular pressure measurements pre- and post-THV deployment

Sponsors & Collaborators

  • Institut de Cardiologie de Montréal

    collaborator UNKNOWN
  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2021-12-28
Completion
2021-12-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05082337 on ClinicalTrials.gov