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New treatment option for Aortic Stenosis Treated With TAVI
Official title Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
ClinicalTrials.gov ID: NCT06689839
What this study is testing
- What it's testing
- 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)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Age ≥ 50 years.
- Patient meets the established criteria and indications for commercially available TAVR via transfemoral access and is scheduled to undergo TAVR per...
- Patient is willing and able to comply with protocol-specified follow-up evaluations.
- Patient is able and willing to provide written informed consent.
- Patient meets all criteria for use of control device (Sentinel device, per IFU). Key
You likely can't join if
- General Exclusion Criteria:
- Patient requires an urgent or emergent TAVR procedure.
- Any treatment cardiovascular procedure performed within 30 days prior to TAVR procedure or planned within 30 days post-TAVR procedure.
- Diagnostic cardiac catheterization within 10 days prior to TAVR procedure.
- Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.
- Prior prosthetic heart valve in any position.
See the full eligibility criteria
- Age ≥ 50 years.
- Patient meets the established criteria and indications for commercially available TAVR via transfemoral access and is scheduled to undergo TAVR per their treating physician.
- Patient is willing and able to comply with protocol-specified follow-up evaluations.
- Patient is able and willing to provide written informed consent.
- Patient meets all criteria for use of control device (Sentinel device, per IFU). Key
- General Exclusion Criteria:
- Patient requires an urgent or emergent TAVR procedure.
- Any treatment cardiovascular procedure performed within 30 days prior to TAVR procedure or planned within 30 days post-TAVR procedure.
- Diagnostic cardiac catheterization within 10 days prior to TAVR procedure.
- Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.
- Prior prosthetic heart valve in any position.
- Known intracardiac thrombus.
- Active infection or endocarditis.
- Patient is contraindicated for anti-platelet and/or anticoagulant therapy.
- Patient refuses blood transfusion.
- Renal insufficiency (creatinine \> 2.5 mg/dL or GFR \< 30) and/or renal replacement therapy at the time of screening.
- Patients with hepatic failure (Child-Pugh class C).
- Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 30%.
- Females who are pregnant or nursing or plan to become pregnant during their participation in the study. Neurological Exclusion Criteria:
- Modified Rankin Scale (mRS) ≥ 2 at screening.
- Cerebrovascular event including TIA within 6 months of the procedure.
- Patient has active major psychiatric disease, known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.
- Patient has severe visual, auditory, or learning impairment.
- Patient has neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. Magnetic Resonance...
- Contraindications to MRI (participants with MR unsafe implants including implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain...
- High risk of complete AV block after TAVR, with the need of permanent pacemaker.
- Claustrophobia precluding MRI scanning. Anatomical and CT Exclusion Criteria:
- Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath, vascular access or filter deployment.
- Presence of cardiovascular implant in aorta and/or peripheral access vessels.
- Access vessels with excessive tortuosity.
- Aortic arch, which is heavily calcified, severely atheromatous, or severely tortuous.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Florida, United States
- Indianappolis, Indiana, United States
- Detroit, Michigan, United States
- Kansas City, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Charlottesville, Virginia, United States
- Spring Hill, Queensland, Australia
- Clayton, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Florida, United States; Indianappolis, Indiana, United States; Detroit, Michigan, United States; Kansas City, Missouri, United States; New York, New York, United States; Cleveland, Ohio, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.