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Procedure

ShortCut™ Device for Preventing Coronary Obstruction

N/A

Waitlist Available

Research Sponsored by Pi-cardia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days post procedure

Awards & highlights

Study Summary

This trialwill study a device used to help prevent the obstruction of coronary arteries during a TAVR procedure.

Who is the study for?

The ShortCut™ Study is for patients needing a valve-in-valve TAVR procedure due to a failed heart valve and at risk of coronary blockage. Participants must consent, have no emergency surgery needs, stable heart function without severe artery disease or recent strokes, MI, infections or life expectancy under one year.Check my eligibility

What is being tested?

This study tests the safety and effectiveness of the ShortCut™ device in splitting bioprosthetic aortic valve leaflets during TAVR procedures to prevent coronary obstruction. It's an open-label trial where all participants receive the same treatment without randomization.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include complications related to heart procedures such as bleeding, blood vessel damage, infection, or reactions to the device material.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intra-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intra-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and intra-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Leaflet splitting success using the ShortCut™ device

ShortCut™ device- and/or ShortCut™ procedure-related mortality and all cause stroke

Secondary outcome measures

Rate of access-related type 3-4 bleeding

Rate of acute kidney injury

Rate of all-cause stroke

+6 more

Other outcome measures

Rate of all-cause mortality

Rate of myocardial infarction with new evidence of coronary artery obstruction requiring intervention

Rate of stroke

Trial Design

1Treatment groups

Experimental Treatment

Group I: ShortCut™Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ShortCut™

2022

N/A

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pi-cardiaLead Sponsor

4 Previous Clinical Trials

160 Total Patients Enrolled

Media Library

ShortCut™ (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04952909 — N/A

Coronary Obstruction Research Study Groups: ShortCut™

Coronary Obstruction Clinical Trial 2023: ShortCut™ Highlights & Side Effects. Trial Name: NCT04952909 — N/A

ShortCut™ (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04952909 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been recruited for this research project?

"Affirmative. The clinical trial is currently open to new participants, as verified by information on the clinicaltrials.gov website. This study was initially posted on January 21st 2022 and last updated in December 6th 2022; it seeks 70 individuals among two medical centres."

Answered by AI

Are senior citizens being included in the recruitment process for this research investigation?

"To be eligible to take part in this trial, patients must be aged 18 or over but no older than 100."

Answered by AI

Are recruitment efforts underway for this research endeavor?

"Affirmative. The clinical trial's information, which was initially published on January 21st of 2022, is currently present on the official website and indicates that 70 participants are required from two sites. As well, it has been recently updated as of December 6th 2022."

Answered by AI

What are the criteria for participating in this clinical trial?

"This clinical trial aims to recruit 70 participants, aged 18 or older and 100 or younger, with a risk of coronary obstruction due to transcatheter aortic valve replacement (TAVR) procedure. Notably, patients must have received written consent prior to any mandated procedures and be eligible for percutaneous valve-in-valve treatment as an approved ViV indication for failed bioprosthetic valves."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The ShortCut™ Study Protocol

2022. "The ShortCut™ Study Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04952909.