Clinical trial NCT06689839: Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Official title: A Prospective, Randomized, Multicenter, Single-blind Trial to Assess the Safety and Effectiveness of the Encompass F2 Cerebral Protection System Vs. Standard of Care (Unprotected or Sentinel® Cerebral Protection System) During Transfemoral Transcatheter Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Stenosis Treated With TAVI
Aortic Diseases
Keywords: Embolic Protection
Transcatheter Aortic Valve Replacement
TAVR
Aortic Valve Stenosis
Aortic Valve Diseases
Lead sponsor: EnCompass Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Avania
name: Insight Medical Consulting
First posted: 2024-11-15
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in 1:1 ratio to:

* Transcatheter Aortic Valve Replacement (TF TAVR) with the F2 Cerebral Protection System (CPS) (treatment group) or
* Transcatheter Aortic Valve Replacement (TF TAVR) with Standard of Care treatment (no embolic protection or use of the commercially available protection device, Sentinel System; control group)
Primary purpose: TREATMENT

Brief 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)

Detailed description: The study is designed to demonstrate that the F2 Cerebral Protection System (CPS) performs in a consistent manner as the control group in terms of safety, and the F2 Cerebral Protection System (CPS) will be superior in performance when compared to the control group in terms of effectiveness in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR).

Eligibility criteria: Key Inclusion 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 Exclusion Criteria:

General Exclusion Criteria:

* Patient requires an urgent or emergent TAVR procedure.
* Any interventional 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 Imaging Exclusion Criteria:

* 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 or eye before TAVR procedure).
* 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.

Primary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 30 days post procedure
measure: Total New Lesion Volume
timeFrame: 8-72 hours post procedure
Secondary outcomes:
measure: Stroke
timeFrame: 30 days post procedure
Other outcomes:
measure: Performance
timeFrame: During procedure
measure: Mortality & Stroke Rates
timeFrame: 30 days post procedure
measure: Freedom from Lesions
timeFrame: 8-72 hours post procedure
measure: Average Lesion Size
timeFrame: 8-72 hours post procedure
measure: Neurological Outcomes-National Institute of Health Stroke Scale (NIHSS)
timeFrame: 30 days post procedure
measure: Neurological Outcomes-Montreal Cognitive Assessment (MoCA)
timeFrame: 30 days post procedure
measure: Neurological Outcomes-Modified Rankin Scale (MRS)
timeFrame: 30 days post procedure
measure: Major Vascular Complication & Bleeding
timeFrame: During procedure
measure: Hospital Readmissions
timeFrame: 30 days post procedure
measure: Index Hospital Length of Stay (LOS)
timeFrame: Through 30 days
measure: Index Hospitalization ICU Length of Stay (LOS)
timeFrame: Through 30 days
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 30 days post procedure
measure: Short Form (SF-12) Questionnaire
timeFrame: 30 days post procedure
Locations:
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Kansas City
country: United States
facility: St. Lukes Hospital Of Kansas City
state: Missouri
city: New York
country: United States
facility: Cumc/Nyph
state: New York
city: Columbus
country: United States
facility: Ohio Health Research Institute (aka Riverside Methodist Hospital)
state: Ohio
Study officials:
References: