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The ShortCut™ Continued Access Study Protocol

NCT06211296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-11-17

Study results available
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Summary

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).

Conditions

  • Valve-in-valve Procedures
  • Aortic Stenosis
  • Coronary; Obstruction

Interventions

DEVICE

Shortcut

Splitting bioprosthetic aortic valve leaflets

Sponsors & Collaborators

  • Pi-cardia

    lead INDUSTRY

Principal Investigators

  • Hadas Givon · Pi-cardia

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2025-05-12
Completion
2025-05-12
FDA Device
Yes

Countries

  • United States

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 NCT06211296 on ClinicalTrials.gov