Videodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA
Launched by XIJING HOSPITAL · Mar 21, 2025
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
As the transcatheter aortic valve implantation (TAVI) procedure matures, complications such as paravalvular regurgitation (PVR), stroke, conduction disturbances, vascular complications, and annular rupture have been targeted for further improving the long-term outcome of TAVI. Paravalvular regurgitation (PVR) is associated with mortality following TAVI, even in those with mild PVR. Accurate procedural assessment of AR-critical for successful TAVI. Aortic root angiography, typically using Seller's visual grading, is the first screening tool used in most laboratories for the detection of post...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Subject has aortic stenosis with indication of TAVI implantation as determined by Heart Team.
- • 2. Patient is at least 18 years of age.
- • 3. Signed informed consent. The patient understands and accepts clinical follow-up.
- Exclusion Criteria:
- • 1. Subject is not willing to provide an informed consent form, or whose legal heirs object to their participation in the study.
- • 2. If the patient is not suitable for participating in the study, based on the evaluation by the operators.
- • 3. Cardiogenic shock.
- • 4. Significant comorbidities precluding clinical follow-up (as judged by investigators).
- • 5. History of TAVI or SAVR.
- • 6. Renal insufficiency (GFR/MDRD \<45 ml/min), which precludes in operator's opinion contrast injection during repeat aortography.
About Xijing Hospital
Xijing Hospital, a prominent medical institution affiliated with the Fourth Military Medical University in Xi'an, China, is dedicated to advancing healthcare through innovative clinical research. Renowned for its comprehensive range of medical services and expertise in various specialties, Xijing Hospital actively sponsors clinical trials aimed at evaluating new therapies, improving patient outcomes, and contributing to scientific knowledge. With a commitment to ethical standards and patient safety, the hospital fosters collaboration among multidisciplinary teams to drive forward the development of effective treatment options that address critical health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Xi'an, Shannxi, China
Patients applied
Trial Officials
Ling Tao, PhD
Study Chair
Xijing Hospital, Xi'an, Shannxi, China
Junbo Ge, PhD
Principal Investigator
Zhongshan hospital, Fudan University, Shanghai, China
Patrick Washington Serruys, PhD
Study Chair
National University of Ireland Galway, Galway, Ireland
Yoshinobu Onuma, Ph D
Study Chair
National University of Ireland Galway, Galway, Ireland
Daxin Zhou, PhD
Study Chair
Zhongshan hospital, Fudan University, Shanghai, China
Rutao Wang, PhD
Study Chair
Xijing Hospital, Xi'an, Shannxi, China
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported