The CAPTIS® Study - Embolic Protection in TAVR

NCT04659538 | Completed

• 1 other identifier: CLD-FLX-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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)

Conditions

Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Safety - Occurrence of MACCE

  Occurrence of all MACCE at 72 hours post procedure, with MACCE defined as all death and all cerebrovascular events (all TIA and stroke).

  72 hours

• Safety - Device related complications

  Number of device related complications \[at 72 hours\]

  72 hours

Secondary Outcomes (4)

• Secondary Safety - Occurrence of MACCE

  30 days

• Secondary Safety - Acute Kidney Injury

  72 hours

• Device feasibility - Histopathologic examination of debris captured and removed by the device

  Day 0

• Technical Device Performance - the ability to deploy and retrieve the device without device malfunction

  Day 0

Study Arms (1)

CAPTIS Embolic Protection

EXPERIMENTAL

TAVR will be performed according to standard institutional practice under local or general anesthesia by the transfemoral approach. The investigational device will be advanced and deployed across the aortic arch covering the ostia of the 3 great vessels (innominate, left carotid, and left-subclavian arteries) at the initiation of the procedure and withdrawn at the completion of the TAVR procedure.

Device: CAPTIS Embolic Protection device

Interventions

CAPTIS Embolic Protection device DEVICE

The CAPTIS Embolic Protection device will be deployed during standard of care TAVR procedure. The device's safety will be assessed up to one month post procedure. The device's technical performance and feasibility to capture and remove debris during the procedure will be evaluated.

CAPTIS Embolic Protection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be ≥18 years of age.
• Patient has clinical indications for TAVR procedure.
• TAVR procedure planned with femoral artery access site
• TAVR device approved for use in the US, Europe or Israel
• Femoral and iliac artery with a minimal luminal diameter of at least 6 mm
• Descending Aorta diameter of 20 to 27mm measured 10cm from the left subclavian, determined by CT scan analysis
• The distance between the innominate and left-subclavian arteries (including their lumens) is less than 65mm
• Patient is willing to comply with protocol-specified preprocedure and follow-up evaluations.
• 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.

You may not qualify if:

• General
• 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
• Hemodialysis shunt, graft, or arterio-venous fistula involving the lower extremity vasculature
• 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
• Hemodynamic instability requiring pharmacological or mechanical circulatory support. Patient in whom hemodynamic instability is expected or at increased risk, will also be excluded.
• Any surgery or procedure (including endovascular) planned for the 30 days post TAVR
• Severe left-ventricle dysfunction with LVEF ≤30%
• Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
• Active or recent bacterial endocarditis
• Active peptic ulcer or upper GI bleeding within the prior 3 months
• A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, ticagrelor, or contrast media, which cannot be adequately pre-medicated or replaced by an alternative agent
• Renal insufficiency (GFR \< 30). Patients on renal replacement therapy (dialysis) can be enrolled into the study.
• Life expectancy \< 12 months due to non-cardiac comorbid conditions
• Patients who refuse blood transfusion
• Chronic or persistent atrial fibrillation, frequent recurring atrial fibrillation, and patients with planned ablation for atrial fibrillation

Sponsors & Collaborators

• Filterlex Medical Ltd.: lead

Study Sites (3)

Wolfson Medical Center

Holon, 5822012, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Related Links

• Sponsor website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 9, 2020
• Study Start: November 24, 2020
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)