MedTrace Logo

Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial

NCT07648693 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-06-15

No results posted yet for this study

Summary

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.

Conditions

  • Transcatheter Aortic Valve Replacement (TAVR)
  • Cerebral Vascular Accident (CVA)/Stroke

Interventions

DEVICE

CHORDS® Cerebral Protection System

Undergo TAVR procedure with the CHORDS® Cerebral Protection System

DEVICE

Sentinel Cerebral Protection System

Undergo TAVR procedure with Sentinel Cerebral Protection System

Sponsors & Collaborators

  • Resonova (Shanghai) Medtech Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07648693 on ClinicalTrials.gov