Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
Key facts
- Where
- Shanghai and Xi'an, ChinaSee the 2 sites
Where in China
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaNo longer taking part
- Xijing hospitalXi'an, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xijing Hospital
- Trial code
- NCT06891079
- Record updated
- 24 March 2025
- Original description
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.Read full original descriptionShow less
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA-A Prospective, Randomized, Controlled, Open-label, Multi-centre, Non-inferiority Trial
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.
Inclusion: 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: History of TAVI or SAVR; Renal insufficiency (GFR/MDRD <45 ml/min), which precludes in operator's opinion contrast injection during repeat aortography; 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; Significant comorbidities precluding clinical follow-up (as judged by investigators).