Electrophysiological Outcomes After Transcatheter Aortic Valve Replacement (TAVR-ELECTRO)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Active, not recruiting

Conditions: Arrhythmia; Aortic Valve Stenosis

Treatments: Procedure: TAVR Aspirin and clopidogrel

Study type: Observational

Funder types: Other

Identifiers

NCT07390513

NCRC2020009 (Other Grant/Funding Number)

2024-2428

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age ≥18 years at the time of transcatheter aortic valve replacement (TAVR). Diagnosis of severe aortic stenosis based on current guideline-recommended echocardiographic criteria.

Undergoing transcatheter aortic valve replacement (TAVR) as part of routine clinical care.

Availability of baseline electrocardiographic assessment, including ambulatory electrocardiographic monitoring for evaluation of premature ventricular contraction (PVC) burden.

Completion of post-procedural rhythm follow-up, including ambulatory electrocardiographic monitoring at 12 months after TAVR.

Ability to provide informed consent or availability of legally authorized consent, as required by the institutional review board.

Exclusion criteria

Absence of premature ventricular contractions at baseline (PVC burden = 0), as PVC response cannot be meaningfully assessed in this population.

Presence of a permanent pacemaker or implantable cardioverter-defibrillator prior to TAVR.

Receipt of catheter ablation for atrial or ventricular arrhythmias before TAVR or during the follow-up period.

Death occurring during the index hospitalization or before completion of rhythm follow-up.

Inability to complete scheduled electrocardiographic or ambulatory rhythm assessments during follow-up.

Missing or incomplete key electrocardiographic, echocardiographic, or follow-up data required for outcome assessment.