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The ShortCut™ Study Protocol

NCT04952909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-03

Study results available
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Summary

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.

Conditions

  • Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure

Interventions

DEVICE

ShortCut™

Splitting bioprosthetic aortic valve leaflets

Sponsors & Collaborators

  • Pi-cardia

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2023-09-30
Completion
2023-12-31

Countries

  • United States
  • France
  • Germany
  • Israel
  • United Kingdom

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 NCT04952909 on ClinicalTrials.gov