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EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
NCT03042104 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
Conditions Studied
Interventions
- DEVICE Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Study Locations (20)
California
- Mills Peninsula Health Services — Burlingame
- Cedars-Sinai Medical Center — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
- Huntington Hospital — Pasadena
- UC Davis Medical Center — Sacramento
- Kaiser San Francisco Medical Center — San Francisco
- Stanford Hospital and Clinics Palo Alto — Stanford
Illinois
- Northwestern University — Chicago
- Rush University Medical Center Chicago — Chicago
- NorthShore University HealthSystem Research Institution — Evanston
- Alexian Brothers Hospital Network — Lisle
- Prairie Education and Research Cooperative — Springfield
Florida
- The Cardiac & Vascular Institute Research Foundation — Gainesville
- University of Florida — Gainesville
Georgia
- Piedmont Heart Institute — Atlanta
- Emory University — Atlanta
Arizona
- Banner University Medical Center — Phoenix
Colorado
- UC Health Northern Colorado (Medical Center of the Rockies) — Loveland
Connecticut
- Yale University — New Haven
District of Columbia
- Washington Hospital Center DC — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 901 participants |
| Start Date | 2017-07-12 |
| Est. Completion | 2032-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03042104
The ClinicalTrials.gov registry entry for NCT03042104 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 901 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Heart Diseases appearing as the primary indexed condition, and to 1 intervention — of which Edwards SAPIEN 3 / SAPIEN 3 Ultra THV 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: NCT03042104 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Illinois, Florida. 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 NCT03042104 about?
NCT03042104 is a clinical study titled "EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis". This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
What is the current status of trial NCT03042104?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 901 participants. The study started on 2017-07-12. Estimated completion is 2032-03.
What conditions does trial NCT03042104 study?
This clinical trial studies the following conditions: Heart Diseases, Aortic Stenosis, Severe. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03042104?
The interventions under investigation include: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03042104?
This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03042104 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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