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The CAPTIS® Study - Embolic Protection in TAVR | Clinical Trials | Clareo Health

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The CAPTIS® Study - Embolic Protection in TAVR

A Prospective, Single Arm, FIH Study to Evaluate the Safety and Feasibility of the CAPTIS Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)

NCT04659538•Filterlex Medical Ltd.

View on ClinicalTrials.gov

Summary

This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR)

Detailed Description

This is a prospective, multi center, single arm, FIH safety and feasibility study enrolling up to 20 patients. Patients undergoing clinically indicated TAVR who comply with the study inclusion/exclusion criteria will be enrolled to have embolic protection with the CAPTIS® Device during the TAVR procedure. Screening activities will include initial screening by the site, analysis of patient CT scan by the sponsor and core-lab, and review of the clinical and imaging data by an eligibility committee to confirm that all inclusion/exclusion criteria are met. Final eligibility for study enrollment is then determined by the investigator in the cardiac catheterization laboratory. Enrolled patients will undergo safety assessment during the procedure, post-procedure, and at 30 days post-procedure; Feasibility evaluation will be assessed during procedure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patient must be ≥18 years of age.
•2. Patient has clinical indications for TAVR procedure.
•3. TAVR procedure planned with femoral artery access site
•4. TAVR device approved for use in the US, Europe or Israel
•5. Femoral and iliac artery with a minimal luminal diameter of at least 6 mm
•6. Descending Aorta diameter of 20 to 27mm measured 10cm from the left subclavian, determined by CT scan analysis
•7. The distance between the innominate and left-subclavian arteries (including their lumens) is less than 65mm
•8. Patient is willing to comply with protocol-specified preprocedure and follow-up evaluations.
•9. The patient has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the clinical site.

Exclusion Criteria

•General
•1. Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test
•2. Hemodialysis shunt, graft, or arterio-venous fistula involving the lower extremity vasculature
•3. Blood dyscrasias: WBC \<5000/microliter, Hb \<10.0 mg/dL, PLT \<100,000/microliter, history of bleeding diathesis, coagulopathy, or conditions associated with increased thrombogenicity
•4. Hemodynamic instability requiring pharmacological or mechanical circulatory support. Patient in whom hemodynamic instability is expected or at increased risk, will also be excluded.
•5. Any surgery or procedure (including endovascular) planned for the 30 days post TAVR
•6. Severe left-ventricle dysfunction with LVEF ≤30%
•7. Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
•8. Active or recent bacterial endocarditis
•9. Active peptic ulcer or upper GI bleeding within the prior 3 months
+16 more criteria

Locations (3)

Wolfson Medical Center

Holon, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Key Dates

Start Date

November 24, 2020

Primary Completion Date

May 3, 2022

Completion Date

May 3, 2022

Last Updated

May 25, 2022

Enrollment

ACTUAL participants

Conditions

Transcatheter Aortic Valve Replacement

Interventions

CAPTIS Embolic Protection device

DEVICE

Short Versus Long Antiplatelet Therapy After TAVI

NCT06518317

Transcatheter Aortic Valve Replacement

View study

RECRUITING

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

NCT04139616

Conduction DisturbancesTranscatheter Aortic Valve Replacement+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The CAPTIS® Study - Embolic Protection in TAVR

Inclusion Criteria

Exclusion Criteria

Short Versus Long Antiplatelet Therapy After TAVI

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