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NCT06034028 · ClinicalTrials.gov registry record · NA

J-Valve TF Early Feasibility Study

A NA study of Aortic Valve Disease and Aortic Valve Insufficiency, sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences.

Active
Registry status
NA
Development phase
25
Enrollment target
9
Study locations

NCT06034028 is a NA study of Aortic Valve Disease and Aortic Valve Insufficiency that is active but no longer recruiting, run by JC Medical, Inc., an affiliate of Edwards Lifesciences. The registered enrollment target is 25 participants, below the 18,615-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower). The trial reports 9 study locations across 8 states.

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The verdict

NCT06034028, a NA study of Aortic Valve Disease and Aortic Valve Insufficiency, is active but no longer recruiting, sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
25 participants
Enrollment target
9
Study locations

Study Summary

The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.

Interventions

  • DEVICE J-Valve TF System

Study Locations (9)

New York

  • University at Buffalo - Buffalo
  • Montefiore Medical Center - The Bronx

Arizona

  • HonorHealth - Scottsdale

District of Columbia

  • MedStar Washington Hospital Center - Washington D.C.

Illinois

  • Advocate Christ Medical Center - Oak Lawn

Louisiana

  • Cardiovascular Institute of the South - Houma

Ohio

  • The Christ Hospital - Cincinnati

Texas

  • Houston Methodist Hospital - Houston

Washington

  • Swedish Medical Center Cherry Hill - Seattle

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2023-10-16
Est. Completion 2029-08-25
Phase NA

What the Registry Record Tells You About NCT06034028

The ClinicalTrials.gov registry entry for NCT06034028 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 18,615-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (100% lower). The listed sponsor is JC Medical, Inc., an affiliate of Edwards Lifesciences, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Aortic Valve Disease appearing as the primary indexed condition, and to 1 intervention - of which J-Valve TF System is the first listed.

NCT06034028 reports 9 study locations spanning 8 distinct geographic areas - top geographies include New York, Arizona, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT06034028 about?

NCT06034028 is a clinical study titled "J-Valve TF Early Feasibility Study". The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aor...

What is the current status of trial NCT06034028?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2023-10-16. Estimated completion is 2029-08-25.

What conditions does trial NCT06034028 study?

This clinical trial studies the following conditions: Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Regurgitation.

What interventions are being tested in trial NCT06034028?

The interventions under investigation include: J-Valve TF System (DEVICE).

Who is sponsoring clinical trial NCT06034028?

This trial is sponsored by JC Medical, Inc., an affiliate of Edwards Lifesciences, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06034028 being conducted?

This trial has 9 study locations across Arizona, District of Columbia, Illinois, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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