Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of … (NCT06891079) | Clinical Trial Compass
By InvitationNot Applicable
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
China320 participantsStarted 2024-03-28
Plain-language summary
This clinical trial, a prospective, randomized, multicenter study, assigns patients to either videodensitometry-guided TAVI or conventional TTE/TEE-guided TAVI (stand of care), with the primary endpoint being regurgitation fraction measured by cardiac magnetic resonance (CMR) at discharge. Current AR assessment methods, like subjective visual grading or intraprocedural TTE, face limitations in objectivity and practicality, whereas videodensitometry offers real-time, quantitative feedback to guide corrective actions (e.g., post-dilation) during TAVI. If proven non-inferior, this approach could streamline workflows by reducing reliance on general anesthesia and complex imaging, potentially lowering complications and expanding accessibility, particularly in centers lacking advanced echocardiography resources.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject has aortic stenosis with indication of TAVI implantation as determined by Heart Team.
. Patient is at least 18 years of age.
. Signed informed consent. The patient understands and accepts clinical follow-up.
Exclusion criteria
. Subject is not willing to provide an informed consent form, or whose legal heirs object to their participation in the study.
. If the patient is not suitable for participating in the study, based on the evaluation by the operators.
. Cardiogenic shock.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CMR-derived regurgitation fraction
Timeframe: at discharge 1 day, an average of 7days