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NCT04415047 · ClinicalTrials.gov registry record · NA
The JenaValve ALIGN-AR Pivotal Trial
A NA study of Aortic Valve Disease and Aortic Valve Insufficiency, sponsored by JenaValve Technology.
- Active
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT04415047: Active NA study of Aortic Valve Disease and Aortic Valve Insufficiency, sponsored by JenaValve Technology.
NCT04415047 is a NA study of Aortic Valve Disease and Aortic Valve Insufficiency that is active but no longer recruiting, run by JenaValve Technology. The registered enrollment target is 180 participants, below the 18,605-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04415047, a NA study of Aortic Valve Disease and Aortic Valve Insufficiency, is active but no longer recruiting, sponsored by JenaValve Technology.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
All-cause mortality within the first 12 months post index procedure
Conditions Studied
Interventions
- DEVICE JenaValve Trilogy Heart Valve System
Study Locations (20)
California
- Cedars Sinai Medical Center - Los Angeles
- Scripps Hospital - San Diego
- California Pacific Medical Center Research Institute - San Francisco
Ohio
- The Christ Hospital - Cincinnati
- Cleveland Clinic Foundation - Cleveland
- Ohio Health Research Institute - Columbus
Georgia
- Piedmont Healthcare - Atlanta
- Emory University Hospital - Atlanta
Michigan
- University of Michigan - Ann Arbor
- Henry Ford Health System - Detroit
Arizona
- TMC HealthCare & PIMA Heart - Tucson
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Florida
- Morton Plant/ BayCare Health - Clearwater
Illinois
- Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health - Oak Lawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2020-05-22 |
| Est. Completion | 2028-08 |
| Phase | NA |
What the registry record for NCT04415047 still lists
NCT04415047 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 18,605-participant average among 15 other Aortic Valve Disease trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Aortic Valve Disease appearing as the primary indexed condition, and to 1 intervention - of which JenaValve Trilogy Heart Valve System is the first listed.
NCT04415047 names 20 study sites across 14 states, led by California, Ohio, Georgia.
Frequently Asked Questions
What is clinical trial NCT04415047 about?
NCT04415047 is a clinical study titled "The JenaValve ALIGN-AR Pivotal Trial". 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 aort...
What is the current status of trial NCT04415047?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2020-05-22. Estimated completion is 2028-08.
What conditions does trial NCT04415047 study?
This clinical trial studies the following conditions: Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Regurgitation, Aortic Insufficiency.
What interventions are being tested in trial NCT04415047?
The interventions under investigation include: JenaValve Trilogy Heart Valve System (DEVICE).
Who is sponsoring clinical trial NCT04415047?
This trial is sponsored by JenaValve Technology, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04415047 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Aortic Valve Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04415047's enrollment target sits among peer trials
180 9th of 15 higher than 7 of 15 other Aortic Valve Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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