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

NCT05492383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2023-04-12

No results posted yet for this study

Summary

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

Conditions

  • Severe Aortic Stenosis

Interventions

DEVICE

TAVI

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

Sponsors & Collaborators

  • Opsens, Inc.

    lead INDUSTRY

Principal Investigators

  • Josep Rodés-Cabau, Dr · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2023-03-03
Completion
2023-03-03

Countries

  • Spain

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 NCT05492383 on ClinicalTrials.gov