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The ENCIRCLE Trial
NCT04153292 · View on ClinicalTrials.gov ↗
Study Summary
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Conditions Studied
Interventions
- DEVICE SAPIEN M3 valve and dock
Study Locations (20)
California
- Scripps Health — La Jolla
- Good Samaritan Hospital — Los Angeles
- Cedars-Sinai Medical Center — Los Angeles
- Kaiser Sunset LA — Los Angeles
- Saint Joseph Hospital — Orange
- California Pacific Medical Center — San Francisco
Florida
- Delray Medical Center — Delray Beach
- Cardiac & Vascular Institute Foundation — Gainesville
- Ascension St. Vincent's Hospital — Jacksonville
- Naples Community Hospital — Naples
- Sarasota Memorial Hospital — Sarasota
Arizona
- Banner University Medical Center — Phoenix
- Saint Josephs Hospital Medical Center Dignity Health — Phoenix
- TMC Healthcare — Tucson
Georgia
- Emory University — Atlanta
- Piedmont Healthcare — Atlanta
Illinois
- Rush University Medical Center — Chicago
- Northshore University Health System — Glenview
Alabama
- Heart Center Hospital — Huntsville
Colorado
- UC Health Northern Colorado (Medical Center of the Rockies) — Loveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2020-11-12 |
| Est. Completion | 2031-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04153292
The ClinicalTrials.gov registry entry for NCT04153292 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 900 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 Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention — of which SAPIEN M3 valve and dock 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: NCT04153292 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT04153292 about?
NCT04153292 is a clinical study titled "The ENCIRCLE Trial". This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be ...
What is the current status of trial NCT04153292?
This trial is currently recruiting. It is a NA study. The enrollment target is 900 participants. The study started on 2020-11-12. Estimated completion is 2031-02-28.
What conditions does trial NCT04153292 study?
This clinical trial studies the following conditions: Mitral Regurgitation, Mitral Valve 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 NCT04153292?
The interventions under investigation include: SAPIEN M3 valve and dock (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04153292?
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 NCT04153292 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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