On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
Public ClinicalTrials.gov record NCT02677974. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02677974
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 510 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 10, 2015 (Actual)
- Primary completion
- Apr 2027 (Estimated)
- Completion
- Aug 2027 (Estimated)
- Last update posted
- Jul 14, 2026
2015 – 2027
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Cardiothoracic & Neurology | Tucson | Arizona | 85718 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Franciscan St. Francis | Indianapolis | Indiana | 46237 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Sanford Medical Center | Fargo | North Dakota | 58122 | — |
| The Lindner Center at The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Providence St. Vincent | Portland | Oregon | 97213 | — |
| University of Texas Southwestern | Dallas | Texas | 75390 | — |
| University of Texas Health Science Center - Houston | Houston | Texas | 77030 | — |
| Baylor Scott & White - Plano | Plano | Texas | 75093 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Carilion Clinic | Roanoke | Virginia | 24014 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| MultiCare Health System | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02677974, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02677974 live on ClinicalTrials.gov.