Status:
ENROLLING_BY_INVITATION
Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
Lead Sponsor:
Xijing Hospital
Conditions:
Aortic Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 endpoi...
Detailed Description
As the transcatheter aortic valve implantation (TAVI) procedure matures, complications such as paravalvular regurgitation (PVR), stroke, conduction disturbances, vascular complications, and annular ru...
Eligibility Criteria
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
- 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).
- History of TAVI or SAVR.
- Renal insufficiency (GFR/MDRD \<45 ml/min), which precludes in operator's opinion contrast injection during repeat aortography.
Key Trial Info
Start Date :
March 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06891079
Start Date
March 28 2024
End Date
December 31 2026
Last Update
March 24 2025
Active Locations (2)
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1
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
2
Xijing hospital
Xi'an, Shannxi, China, 71000