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Tests treatment safety and results for Transcatheter Aortic Valve Replacement (TAVR)
Official title Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
ClinicalTrials.gov ID: NCT07648693
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- General
- Contraindications to MRI, or planned implantation of an MRI-incompatible device at the index procedure, or planned implantation of an...
- 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
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanchang, Jiangxi, China
- Qingdao, Shandong, China
- Chengdu, Sichuan, China
- Wenzhou, Zhejiang, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.