Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING

On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study

NCT02677974 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the proposed study is to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The objective will be to compare adverse event rates for patients in subgroups as listed below targeted at 1.8 (range 1.5 to 2.0) per On-X instructions for use to rates from the previous IDE trial (G050208).

Interventions

  • DEVICE On-X Aortic Heart Valve replacement

Study Locations (20)

Texas

  • University of Texas Southwestern — Dallas
  • University of Texas Health Science Center - Houston — Houston
  • Baylor Scott & White - Plano — Plano

Ohio

  • The Lindner Center at The Christ Hospital — Cincinnati
  • Cleveland Clinic — Cleveland

Virginia

  • Sentara Norfolk General Hospital — Norfolk
  • Carilion Clinic — Roanoke

Washington

  • Swedish Medical Center — Seattle
  • MultiCare Health System — Tacoma

Other

  • Blackpool Victoria Hospital — Blackpool
  • Hull & East Yorkshire Hospitals — Hull

Arizona

  • Arizona Cardiothoracic & Neurology — Tucson

Connecticut

  • Hartford Hospital — Hartford

Indiana

  • Franciscan St. Francis — Indianapolis

Trial Details

FieldValue
Enrollment Target 510 participants
Start Date 2015-11-10
Est. Completion 2027-08

Sponsor

On-X Life Technologies

2 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02677974

The ClinicalTrials.gov registry entry for NCT02677974 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 510 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is On-X Life Technologies, which has 2 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 Thrombotic and Bleeding Events appearing as the primary indexed condition, and to 1 intervention — of which On-X Aortic Heart Valve replacement 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: NCT02677974 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, Ohio, Virginia. 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 NCT02677974 about?

NCT02677974 is a clinical study titled "On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study". The purpose of the proposed study is to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The object...

What is the current status of trial NCT02677974?

This trial is currently active not recruiting. The enrollment target is 510 participants. The study started on 2015-11-10. Estimated completion is 2027-08.

What conditions does trial NCT02677974 study?

This clinical trial studies the following conditions: Thrombotic and Bleeding Events. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02677974?

The interventions under investigation include: On-X Aortic Heart Valve replacement (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02677974?

This trial is sponsored by On-X Life Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02677974 being conducted?

This trial has 20 study locations across Arizona, Connecticut, Indiana, Maine, North Dakota. 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