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Study completed

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

NCT No.: NCT04952909

Study Type: INTERVENTIONAL

Phase: n/a

Region: California - Northern

Acronym: 

Official Title

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

Purpose

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 transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.

Detailed Description

Additional Principal Investigator for this trial: Andrew Rassi, San Francisco, CA.

Sex

Male & Female

Age Limit

Eligibility Criteria

Inclusion Criteria

• Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.

• Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.

Exclusion Criteria

• An excessive aortic valve leaflet Calcium morphology or anatomy not suitable for the use of the ShortCut™ device.

• Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated• or treatment of such disease = 1 month prior to index procedure.

• CVA or TIA = 6 months prior to index procedure, or severe neurological disability.

• Myocardial infarction (MI) = 6 weeks prior to index procedure.

• Hemodynamic or respiratory instability.

• Left ventricle ejection fraction < 30%.

• Ongoing severe infection, sepsis or endocarditis.

• Renal insufficiency

• Need for emergency surgery for any reason.

• Life expectancy is less than 1 year.

Keywords and/or Specific Medical Conditions

  • Cardiology

Sponsors

  • Pi-cardia

KP Clinical Facility

Clinical Area

  • Cardiology

Principal Investigator

Jacob Mishell  

Contact Information

 - 
- All Kaiser Permanente Northern California Medical Centers

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