Long-term Prognosis and Valve Durability of TAVR

Recruiting

• Conditions: Aortic Valve Stenosis and Insufficiency

• Registration Number: NCT06379386
• Lead Sponsor: Xijing Hospital

Brief Summary

This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Last Update Submitted: 2024-04-18
• Study First Posted: 2024-04-23
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Valve-related long-term clinical efficacy	5 years	* Freedom from bioprosthetic Valve Failure (defined as: Valve- related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration; * Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies); * Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)
All-casuse mortality	5 years	All-casuse mortality including cardiac death and non-cardiac death

Secondary Outcome Measures

Name	Time	Method
Rate of technical success	at exit from procedure room	* Freedom from mortality; * Successful access, delivery of the device, and retrieval of the delivery system; * Correct positioning of a single prosthetic heart valve into the proper anatomical location; * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Combined early safety and clinical efficacy outcomes	30 days	Composed by all-cause mortality, all strokes, life-threatening or fatal bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure-related conduction abnormalities, conduction block and arrhythmia, surgery or intervention related to the device, any hospitalization, myocardial infarction, any other adverse events
Rate of device success	discharge or 30 days	* Technical success; * Freedom from mortality; * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication; * Intended performance of the valve (mean gradient\<20mmHg, and less than moderate aortic regurgitation)
Combined clinical efficacy outcomes	5 years and 10 years	Combined clinical efficacy outcomes as composed by all-cause mortality (cardiac/non-cardiac), all strokes, any hospitalization
Valve-related long-term clinical efficacy	10 years	* Freedom from bioprosthetic Valve Failure (defined as: Valve- related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration; * Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies); * Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shannxi, China