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ACTIVE NOT RECRUITING

Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)

NCT05082454 · View on ClinicalTrials.gov ↗

Study Summary

The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.

Conditions Studied

Interventions

  • DEVICE Open repair

Study Locations (11)

Other

  • Medizinische Hochschule Hannover (MHH) — Hanover
  • University Hospital Magdeburg — Magdeburg
  • Policlinico S. Orsola-Malpighi — Bologna
  • Hospital Germans Trias i Pujol — Badalona
  • Hospital de la Santa Creu i Sant Pau — Barcelona
  • Castle Hill Hospital — Cottingham
  • St Bartholomew's Hospital — London
  • Newcastle Freeman Hospital — Newcastle

Pennsylvania

  • Geisinger Health System — Danville

Texas

  • Baylor College of Medicine — Houston

Virginia

  • VCU Medical Center Main Hospital — Richmond

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2021-10-20
Est. Completion 2029-03-31

Sponsor

JOTEC

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05082454

The ClinicalTrials.gov registry entry for NCT05082454 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is JOTEC, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Aortic Valve Disease appearing as the primary indexed condition, and to 1 intervention — of which Open repair is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05082454 reports 11 study locations spanning 4 distinct geographic areas — top geographies include Other, Pennsylvania, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05082454 about?

NCT05082454 is a clinical study titled "Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)". The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.

What is the current status of trial NCT05082454?

This trial is currently active not recruiting. The enrollment target is 108 participants. The study started on 2021-10-20. Estimated completion is 2029-03-31.

What conditions does trial NCT05082454 study?

This clinical trial studies the following conditions: Aortic Valve Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05082454?

The interventions under investigation include: Open repair (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05082454?

This trial is sponsored by JOTEC, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05082454 being conducted?

This trial has 11 study locations across Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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