Who is sponsoring NCT04659538?

NCT04659538 is sponsored by Filterlex Medical Ltd..

What drugs are being tested in NCT04659538?

Interventions in NCT04659538: CAPTIS Embolic Protection device.

What condition does NCT04659538 study?

NCT04659538 studies Transcatheter Aortic Valve Replacement.

Is NCT04659538 still recruiting?

NCT04659538 is currently completed. Last updated 25 May 2022.

Last reviewed 2022-05-25 · How we verify

NCT04659538

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The CAPTIS® Study - Embolic Protection in TAVR

Completed NA Last updated 25 May 2022

What this trial tests

NA trial testing CAPTIS Embolic Protection device in Transcatheter Aortic Valve Replacement in 20 participants. Completed in 3 May 2022.

Timeline

24 November 2020

Primary endpoint
3 May 2022

3 May 2022

Quick facts

Lead sponsor	Filterlex Medical Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	20
Start date	24 November 2020
Primary completion	3 May 2022
Estimated completion	3 May 2022
Sites	3 locations across Israel

Drugs / interventions tested

CAPTIS Embolic Protection device

Conditions studied

Transcatheter Aortic Valve Replacement — all drugs for Transcatheter Aortic Valve Replacement →

Sponsor

Filterlex Medical Ltd.

Who can join

18 and older, any sex, with Transcatheter Aortic Valve Replacement. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Fighting Cardiac Thromboembolism during Transcatheter Procedures: An Update on the Use of Cerebral Protection Devices in Cath Labs and EP Labs.
Preda A, Montalto C, Galasso M, Munafò A, et al · · 2023 · cited 8× · PMID 37763223 · DOI 10.3390/life13091819
First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement.
Danenberg H, Vaknin-Assa H, Makkar R, Virmani R, et al · · 2023 · cited 4× · PMID 37916296 · DOI 10.4244/eij-d-23-00465

Verify or expand the search:

Other recruiting trials for Transcatheter Aortic Valve Replacement

Currently open trials in the same condition.

NCT06559332 — Coronary Artery Disease Assessment Strategies in TAVI Patients · NA · recruiting
NCT06896227 — TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics · NA · recruiting
NCT06420830 — Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis. · recruiting
NCT05758701 — CT TAVR Abdomen Study · Phase 4 · recruiting
NCT06000943 — Ischemic And Bleeding Risk Assessment After TAVR · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04659538 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Filterlex Medical Ltd.
Last refreshed: 25 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04659538.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing