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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 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. The trial reports 20 study locations across 12 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04952909
The ClinicalTrials.gov registry entry for NCT04952909 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pi-cardia, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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