Evaluating long-term outcomes of TAVR for aortic valve disease

Long-term Prognosis and Valve Durability of Transcatheter Aortic Valve Replacement for Aortic Valve Disease: a Real-world, Prospective, Single-center, Observational Study

This study is looking at how well transcatheter aortic valve replacement (TAVR) works for people with severe aortic valve problems over a long period of time.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xijing Hospital (other)
• Locations: 1 site (Xi'an, Shannxi)
• Trial ID: NCT06379386 on ClinicalTrials.gov

What this trial studies

This observational registry focuses on assessing the long-term prognosis and durability of transcatheter aortic valve replacement (TAVR) in patients with severe aortic valve stenosis or insufficiency. It will collect baseline characteristics, procedural data, and clinical outcomes in a real-world setting to provide insights into the effectiveness of TAVR over time. The study aims to gather comprehensive data to better understand patient outcomes following this intervention.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with severe aortic valve regurgitation who have been evaluated by the Heart team and are eligible for TAVR therapy.

Not a fit: Patients who cannot provide informed consent or are participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the long-term effectiveness and durability of TAVR, guiding treatment decisions for patients with aortic valve disease.

How similar studies have performed: Other studies have shown success in evaluating TAVR outcomes, making this approach both relevant and supported by existing literature.

Eligibility criteria

Inclusion Criteria:

Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.

2\. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form

* 1\. Patients with aortic stenosis or aortic valve insufficiency who were evaluated by the Heart team and underwent TAVR therapy
* 2\. Patients who understand the purpose of the study, agree to participate in the trial and sign the informed consent form

Exclusion Criteria:

* 1\. Patients who cannot provide informed consent
* 2\. Patients who are participating in other clinical trials

Where this trial is running

Xi'an, Shannxi

• Xijing Hospital — Xi'an, Shannxi, China (RECRUITING)

Study contacts

• Study coordinator: Rutao Wang, M.D, Ph.D

Conditions: Aortic Valve Stenosis and Insufficiency, Aortic Valve Disease, TAVR, Prognosis, Valve durability