The JenaValve ALIGN-AR Pivotal Trial
Public ClinicalTrials.gov record NCT04415047. 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.
Official title
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
Study identification
- NCT ID
- NCT04415047
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 180 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
- May 22, 2020 (Actual)
- Primary completion
- Aug 29, 2023 (Estimated)
- Completion
- Aug 2028 (Estimated)
- Last update posted
- Sep 13, 2022
2020 – 2028
United States locations
- U.S. sites
- 30
- U.S. states
- 21
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| TMC HealthCare & PIMA Heart | Tucson | Arizona | 85712 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Scripps Hospital | San Diego | California | 92121 | — |
| California Pacific Medical Center Research Institute | San Francisco | California | 94109 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Morton Plant/ BayCare Health | Clearwater | Florida | 33756 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health | Oak Lawn | Illinois | 60453 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Minneapolis Heart Institute/ Abbott Northwestern | Minneapolis | Minnesota | 55407 | — |
| Barnes-Jewish Hospital / Washington University | St Louis | Missouri | 63110 | — |
| Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital | Piscataway | New Jersey | 08901 | — |
| New York-Presbyterian/ Columbia University Medical Center | New York | New York | 10032 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Allegheny-Singer Health Network | Pittsburgh | Pennsylvania | 15212 | — |
| Lankenau | Wynnewood | Pennsylvania | 19096 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Methodist Le Bonheur Healthcare | Memphis | Tennessee | 38104 | — |
| Baylor Scott & White Research Institute | Dallas | Texas | 75201 | — |
| Houston Methodist | Houston | Texas | 77030 | — |
| Memorial Hermann - Texas Medical Center | Houston | Texas | 77030 | — |
| Intermountain Medical Center Heart Institute | Salt Lake City | Utah | 84111 | — |
| Sentara Hospitals | Norfolk | Virginia | 23502 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04415047, 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 Sep 13, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04415047 live on ClinicalTrials.gov.