CHORDS Cerebral Protection During TAVR

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized trial enrolls about 240 adults with symptomatic severe aortic stenosis undergoing TAVR. Participants are assigned to TAVR with CHORDS cerebral protection versus the Sentinel protection device, with follow-up at 30 and 90 days to monitor safety and effectiveness. The study uses DW-MRI and clinical outcomes to assess whether capturing and removing embolic debris during TAVR can improve neurologic safety. Enrollment requires suitable vessel anatomy and the ability to consent and comply with follow-up evaluations. Results will inform whether CHORDS offers a meaningful advantage over an established cerebral protection approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

General

* 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
* Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
* Contraindication to antiplatelet and/or anticoagulant therapy, nitinol , or contrast media, or refusal to receive blood transfusions
* Vulnerable populations, including those unable to adequately understand the trial, those potentially subject to undue influence or coercion, those unable to complete the informed consent process, and those with severe disabling dementia or cognitive impairment Anatomic
* Vasculature (ie, right radial/brachial artery, carotid artery) precluding the device access
* Patients whose brachiocephalic or left carotid artery reveals significant stenosis（\>70%）, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium

Where it's running

• The First Affiliated Hospital of Bengbu Medical College
  Bengbu, Anhui, China Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting
• Beijing Anzhen Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
  Chongqing, Chongqing Municipality, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Xu
• Email: j.xu@resonmed.com
• Phone: 021-50206611

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.