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ACTIVE NOT RECRUITING NA

Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

NCT03635424 · View on ClinicalTrials.gov ↗

Study Summary

The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR

Conditions Studied

Interventions

  • DEVICE Medtronic TAVR Systems

Study Locations (20)

Florida

  • Morton Plant Hospital — Clearwater
  • HealthPark Medical Center — Fort Myers
  • Tallahassee Memorial Hospital — Tallahassee

New York

  • North Shore University Hospital — Manhasset
  • The Mount Sinai Hospital — New York
  • Saint Francis Hospital — Roslyn

California

  • Scripps Memorial Hospital La Jolla — La Jolla
  • Los Robles Hospital & Medical Center — Thousand Oaks

Massachusetts

  • Massachusetts General Hospital — Boston
  • Beth Israel Deaconess Medical Center — Boston

Michigan

  • University of Michigan Health System — Ann Arbor
  • Spectrum Health Hospital — Grand Rapids

Ohio

  • University Hospitals Cleveland Medical Center — Cleveland
  • OhioHealth Riverside Methodist Hospital — Columbus

Arizona

  • Abrazo Arizona Heart Hospital — Phoenix

Connecticut

  • Yale New Haven Hospital — New Haven

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2018-10-30
Est. Completion 2030-12
Phase NA

Sponsor

Medtronic Cardiovascular

49 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03635424

The ClinicalTrials.gov registry entry for NCT03635424 describes a study currently listed as active not 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 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiovascular, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Bicuspid Aortic Valve appearing as the primary indexed condition, and to 1 intervention — of which Medtronic TAVR Systems 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: NCT03635424 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, New York, California. 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 NCT03635424 about?

NCT03635424 is a clinical study titled "Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study". The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR

What is the current status of trial NCT03635424?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2018-10-30. Estimated completion is 2030-12.

What conditions does trial NCT03635424 study?

This clinical trial studies the following conditions: Bicuspid Aortic Valve. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03635424?

The interventions under investigation include: Medtronic TAVR Systems (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03635424?

This trial is sponsored by Medtronic Cardiovascular, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03635424 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. 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