Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06689839 · ClinicalTrials.gov registry record · NA
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
A NA study of Aortic Diseases and Aortic Stenosis Treated With TAVI, sponsored by EnCompass Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 10
- Study locations
NCT06689839: Recruiting NA study of Aortic Diseases and Aortic Stenosis Treated With TAVI, sponsored by EnCompass Technologies.
NCT06689839 is a NA study of Aortic Diseases and Aortic Stenosis Treated With TAVI that is actively recruiting participants, run by EnCompass Technologies. The registered enrollment target is 500 participants, below the 1,481-participant average among 7 other Aortic Diseases trials with a reported enrollment target (66% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06689839, a NA study of Aortic Diseases and Aortic Stenosis Treated With TAVI, is actively recruiting participants, sponsored by EnCompass Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 10
- Study locations
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)
Primary Outcome
MACCE includes the composite of death, all stroke, acute kidney injury (AKI) stage 3 or 4 within 7 days post-index procedure Valve Academic Research Consortium 3 (VARC-3) and any major vascular complication (VARC-3)
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 |
What NCT06689839 shows while recruiting
NCT06689839 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 1,481-participant average among 7 other Aortic Diseases trials with a reported enrollment target (66% lower).
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.
NCT06689839 lists 10 locations in 9 states (Ohio, Florida, Indiana).
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.
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).
Who is sponsoring clinical trial NCT06689839?
This trial is sponsored by EnCompass Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Aortic Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta
RECRUITING · NA
-
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
RECRUITING
-
Montalcino Aortic Consortium: Precision Medicine for Heritable Thoracic Aortic Disease
RECRUITING
-
Intervascular Post-Market Clinical Follow-Up (PMCF) Registry
RECRUITING
-
Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters
RECRUITING · Phase 4
-
Development of CIRC Technologies
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00001230 · 500 participants
Host Response to Infection and Treatment in Filarial Diseases
- NCT00001529 · 500 participants
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
- NCT00697411 · 500 participants
Study of Selected X-Linked Disorders: Aicardi Syndrome
- NCT00903110 · 500 participants
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI