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RECRUITING NA

The JenaValve ALIGN-AR LVAD Registry

NCT06594705 · View on ClinicalTrials.gov ↗

Study Summary

To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR

Interventions

  • DEVICE JenaValve Trilogy Heart Valve System

Study Locations (14)

Georgia

  • Emory University — Atlanta
  • Piedmont — Atlanta

Michigan

  • University of Michigan — Ann Arbor
  • Henry Ford Hospital — Detroit

Missouri

  • Washington University in St. Louis — St Louis
  • Washington University, St. Louis — St Louis

California

  • Cedars-Sinai Medical Center — Los Angeles

District of Columbia

  • Medstar Washington Hospital Center — Washington D.C.

Illinois

  • Advocate Christ Medical Center — Oak Lawn

Minnesota

  • Minneapolis Heart Institute Foundation — Minneapolis

New York

  • Columbia University Medical Center/New York-Presbyterian Hospital — New York

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2024-12-09
Est. Completion 2027-08
Phase NA

Sponsor

JenaValve Technology

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06594705

The ClinicalTrials.gov registry entry for NCT06594705 describes a study currently listed as recruiting. It is categorized as NA, 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 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is JenaValve Technology, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 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. 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: NCT06594705 reports 14 study locations spanning 11 distinct geographic areas — top geographies include Georgia, Michigan, Missouri. 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 NCT06594705 about?

NCT06594705 is a clinical study titled "The JenaValve ALIGN-AR LVAD Registry". To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR

What is the current status of trial NCT06594705?

This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-12-09. Estimated completion is 2027-08.

What conditions does trial NCT06594705 study?

This clinical trial studies the following conditions: Aortic Valve Disease, Aortic Valve Insufficiency, Left Ventricular Dysfunction, Aortic Regurgitation, Aortic Insufficiency. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06594705?

The interventions under investigation include: JenaValve Trilogy Heart Valve System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06594705?

This trial is sponsored by JenaValve Technology, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06594705 being conducted?

This trial has 14 study locations across California, District of Columbia, Georgia, Illinois, Michigan. 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