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The CONFORMAL Early Feasibility Study
NCT03616028 · View on ClinicalTrials.gov ↗
Study Summary
An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
Conditions Studied
Interventions
- DEVICE left atrial appendage closure
Study Locations (11)
New York
- Mount Sinai — New York
- Columbia University Medical Center/NYPH — New York
Tennessee
- Erlanger Health System — Chattanooga
- Vanderbilt University Medical Center — Nashville
Texas
- Texas Cardiac Arrhythmia Institute — Austin
- Baylor Scott & white Research Institute — Plano
Arkansas
- St. Bernards Medical Center — Jonesboro
California
- Pacific Heart Institute — Santa Monica
New Hampshire
- Catholic Medical Center — Manchester
Ohio
- The Christ Hospital — Cincinnati
Pennsylvania
- Lankenau Heart Institute — Wynnewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2019-02-22 |
| Est. Completion | 2028-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03616028
The ClinicalTrials.gov registry entry for NCT03616028 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 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Conformal Medical, which has 29 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 Non-valvular Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention — of which left atrial appendage closure 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: NCT03616028 reports 11 study locations spanning 8 distinct geographic areas — top geographies include New York, Tennessee, Texas. 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 NCT03616028 about?
NCT03616028 is a clinical study titled "The CONFORMAL Early Feasibility Study". An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
What is the current status of trial NCT03616028?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 64 participants. The study started on 2019-02-22. Estimated completion is 2028-06.
What conditions does trial NCT03616028 study?
This clinical trial studies the following conditions: Non-valvular Atrial Fibrillation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03616028?
The interventions under investigation include: left atrial appendage closure (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03616028?
This trial is sponsored by Conformal Medical, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03616028 being conducted?
This trial has 11 study locations across Arkansas, California, New Hampshire, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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