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Trials / Active Not Recruiting

Active Not RecruitingNCT07390513

Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
1,000 (estimated)
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The TAVR-ELECTRO Registry (Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement) is a single-center, observational cohort study designed to systematically evaluate the occurrence, temporal evolution, and determinants of cardiac arrhythmias following transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis. This registry retrospectively enrolls consecutive patients undergoing TAVR at Fuwai Hospital, Chinese Academy of Medical Sciences, and collects comprehensive clinical, echocardiographic, electrocardiographic, and procedural data. Particular emphasis is placed on post-procedural electrophysiological outcomes, including ventricular arrhythmias, atrial arrhythmias, and conduction disturbances. Serial rhythm assessments using standard electrocardiography and ambulatory electrocardiographic monitoring are performed during follow-up to characterize arrhythmic burden and its dynamic changes over time. The primary objective of the TAVR-ELECTRO Registry is to identify clinical, haemodynamic, and procedural factors associated with post-TAVR arrhythmic outcomes and recovery patterns, thereby improving the understanding of electrophysiological remodeling after TAVR and informing post-procedural risk stratification and management strategies.

Conditions

Interventions

TypeNameDescription
PROCEDURETAVR Aspirin and clopidogrelThis is an observational registry study. All participants undergo transcatheter aortic valve replacement (TAVR) as part of standard clinical care for severe aortic stenosis. The choice of valve type (balloon-expandable or self-expanding), valve brand, valve size, access route, and peri-procedural management strategies are determined by the local heart team according to current clinical guidelines and routine practice. No additional investigational intervention is mandated by the registry protocol. The study does not alter clinical decision-making, procedural techniques, or post-procedural treatment strategies. Instead, the registry systematically collects clinical, echocardiographic, electrocardiographic, and procedural data before and after TAVR to evaluate electrophysiological outcomes. Post-procedural rhythm assessment, including standard electrocardiography and ambulatory electrocardiographic monitoring, is performed as part of routine follow-up care. Data on ventricular arrhythm

Timeline

Start date
2022-01-01
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2026-02-05
Last updated
2026-02-05

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07390513. Inclusion in this directory is not an endorsement.