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Search / Trial NCT06891079

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

Aortic Stenosis Transcatheter Aortic Valve Implantation Videodensitometry Paravalvular Regurgitation

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.

Locations

Shanghai, Shanghai, China

Xi'an, Shannxi, China

Patients applied

0 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