Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04415047 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

The JenaValve ALIGN-AR Pivotal Trial

Study acronym: ALIGN-AR
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 13, 2022 (before its estimated August 29, 2023 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jun 2022 to Aug 29, 2023v9 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 24 to 30
    • Study completion date: Jun 2027 to Aug 2028
    • Publications: 7 to 10
  2. Study sites: 19 to 24
    • Interventions: JenaValve Pericardial TAVR System (Device) to JenaValve Trilogy Heart Valve System (Device)
    • Study title shortened, about 5 words
    v8
  3. Study sites: 15 to 19v7
  4. Enrollment target: 50 to 180v6 Show 7 more changesShow less
    • Primary completion date: May 2021 to Jun 2022
    • Primary endpoints: 1 to 8
    • Study sites: 13 to 15
    • Study completion date: Dec 2025 to Jun 2027
    • Start date: Jul 9, 2020 to May 22, 2020
    • Secondary endpoints: 4 to 1
    • Publications: 4 to 7
  5. Study sites: 12 to 13v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 10 to 12v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 15, 2020 to Jul 9, 2020
    • Site details revised at 10 of 10 sites
    v3
  3. Secondary endpoints revised (4)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04415047
Lead Sponsor JenaValve Technology, Inc.
Conditions
(from sponsor)		 Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
Related terms Aortic Valve Disease, Aortic Valve Insufficiency, Heart Valve Diseases
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov