Health Trials

About this trial

This is a prospective, multi-center, randomized controlled study. The goal of the study is to assess the safety and effectiveness of the Resonova® CHORDS® Cerebral Protection System in capturing and removing embolic debris during Transcatheter Aortic Valve Replacement (TAVR). A total of 240 eligible participants will be enrolled and randomized in a 1:1 ratio to undergo TAVR either with the CHORDS® Cerebral Protection System (Test group) or the Sentinel System (Control group).All the participants will be followed up at 30 days and 90 days post-procedure.

Eligibility criteria

Qualifiers

Male or non-pregnant female, ≥18 years

Patients with symptomatic severe aortic stenosis who are scheduled to undergo TAVR with commercialized transcatheter aortic valve system.

Compatible left common carotid artery (6.5-10 mm) and brachiocephalic artery (9-15mm) diameters without significant stenosis (> 70%)

Patients who are able to understand the study objectives, voluntarily participate, sign the informed consent form, and are willing to undergo required examinations and clinical follow-up.

Disqualifiers

Contraindications to MRI, or planned implantation of an MRI-incompatible device at the index procedure, or planned implantation of an MRI-incompatible pacemaker or defibrillator within 30 days post-procedure.

Acute myocardial infarction ≤ 30 days before the intended treatment

Pure aortic regurgitation

Pre-existing prosthetic aortic valve

Trial design

Treatments tested in this trial

  • CHORDS® Cerebral Protection System
  • Sentinel Cerebral Protection System

Treatment groups

240 Participants
are divided into 2 treatment groups

Locations

15
The First Affiliated Hospital of Bengbu Medical College BengbuAnhui, China
Anhui Provincial Hospital HefeiAnhui, China
Beijing Anzhen Hospital, Capital Medical University BeijingBeijing Municipality, China
The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army ChongqingChongqing Municipality, China

Sponsors and collaborators

Resonova (Shanghai) Medtech Limited

Lead sponsor

Source ClinicalTrials.gov