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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
NCT06689839 · View on ClinicalTrials.gov ↗
Study Summary
The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)
Conditions Studied
Interventions
- DEVICE F2 Filter and Delivery System
- PROCEDURE Transcatheter Aortic Valve Replacement (TAVR)
Study Locations (10)
Ohio
- Cleveland Clinic Foundation — Cleveland
- Ohio Health Research Institute (aka Riverside Methodist Hospital) — Columbus
Florida
- NCH Baker Hospital-Naples Heart Institute — Naples
Indiana
- St. Vincent Hospital — Indianappolis
Michigan
- Henry Ford Hospital — Detroit
Missouri
- St. Lukes Hospital Of Kansas City — Kansas City
New York
- Cumc/Nyph — New York
Virginia
- University of Virginia Medical Center — Charlottesville
Queensland
- St Andrews War Memorial Hospital — Spring Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-09-09 |
| Est. Completion | 2027-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06689839
The ClinicalTrials.gov registry entry for NCT06689839 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 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EnCompass Technologies, which has 1 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 Aortic Diseases appearing as the primary indexed condition, and to 2 interventions — of which F2 Filter and Delivery 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: NCT06689839 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Ohio, Florida, Indiana. 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 NCT06689839 about?
NCT06689839 is a clinical study titled "Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR". The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)
What is the current status of trial NCT06689839?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2025-09-09. Estimated completion is 2027-01.
What conditions does trial NCT06689839 study?
This clinical trial studies the following conditions: Aortic Diseases, Aortic Stenosis Treated With TAVI. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06689839?
The interventions under investigation include: F2 Filter and Delivery System (DEVICE), Transcatheter Aortic Valve Replacement (TAVR) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06689839?
This trial is sponsored by EnCompass Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06689839 being conducted?
This trial has 10 study locations across Florida, Indiana, Michigan, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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