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NCT04952909 · ClinicalTrials.gov registry record · NA
The ShortCut™ Study Protocol
A NA study of Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure, sponsored by Pi-cardia.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT04952909: Completed NA study of Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure, sponsored by Pi-cardia.
NCT04952909 is a NA study of Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure that has completed, run by Pi-cardia. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04952909, a NA study of Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure, has completed, sponsored by Pi-cardia.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DEVICE ShortCut™
Study Locations (20)
Other
- CHU de Bordeaux (Bordeaux University Hospital) - Bordeaux
- Institute Mutualiste Montsouris - Paris
- Clinique Pasteur - Toulouse
- German Heart Institute Berlin - Berlin
- University Hospital Hamburg - Hamburg
- Leipzig Heart Institute - Leipzig
- Sha'are Tzedek Medical Center - Jerusalem
California
- Smidt Heart Institute Cedars-Sinai Medical - Los Angeles
- Kaiser Permanente - San Francisco Medical Center - San Francisco
- Los Robles Regional Medical Center - Thousand Oaks
Arizona
- Tucson Medical Center - Tucson
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Illinois
- Advocate Christ Medical Center - Oak Lawn
Michigan
- University of Michigan - Ann Arbor
New Jersey
- Morristown Medical Center - Morristown
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-01-21 |
| Est. Completion | 2023-12-31 |
| Phase | NA |
What the finished NCT04952909 record still lists
NCT04952909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure appearing as the primary indexed condition, and to 1 intervention - of which ShortCut™ is the first listed.
NCT04952909 names 20 study sites across 12 states, led by Other, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04952909 about?
NCT04952909 is a clinical study titled "The ShortCut™ Study Protocol". 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 (TAV...
What is the current status of trial NCT04952909?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2022-01-21. Estimated completion is 2023-12-31.
What conditions does trial NCT04952909 study?
This clinical trial studies the following conditions: Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure.
What interventions are being tested in trial NCT04952909?
The interventions under investigation include: ShortCut™ (DEVICE).
Who is sponsoring clinical trial NCT04952909?
This trial is sponsored by Pi-cardia, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04952909 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04952909's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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