CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
ShortCut™device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04952909
NCT04952909N/ACompleted
CompareCT.gov

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)

Pi-cardia·interventional·Posted Jul 7, 2021·Updated Feb 3, 2025

In Brief

A clinical study evaluating ShortCut™ for Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure. Completed, enrolled 60 participants across 23 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRisk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
CountriesFrance, Germany, Israel, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 7, 2021
Enrollment StartJan 21, 2022
Primary CompletionSep 30, 2023
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.0 years ago

Interventions

ShortCut™device

Splitting bioprosthetic aortic valve leaflets