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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis; Arrhythmia
• Intervention / Treatment: Procedure: TAVR Aspirin and clopidogrel

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100037
    • National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients with severe aortic stenosis who undergo transcatheter aortic valve replacement (TAVR) as part of routine clinical care at Fuwai Hospital, Chinese Academy of Medical Sciences. Eligible participants include consecutive patients who receive TAVR and undergo systematic post-procedural rhythm evaluation as part of standard follow-up.

The registry focuses on patients with available baseline and follow-up electrocardiographic assessments, allowing for longitudinal evaluation of cardiac arrhythmias after TAVR. Particular attention is given to ventricular arrhythmias, including premature ventricular contractions, as well as atrial arrhythmias and conduction disturbances occurring during follow-up.

This study population reflects a real-world cohort of patients treated with contemporary TAVR devices and management strategies, providing comprehensive clinical, echocardiographic, electrocardiographic, and procedural data to characterize electrophysi

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature Ventricular Contraction (PVC) Response at 12-Month Follow-up	PVC response is defined as a reduction of ≥50% in premature ventricular contraction burden at 12 months compared with baseline. PVC burden is quantified as the total number of premature ventricular contractions per 24 hours, assessed by 24-hour ambulatory electrocardiographic monitoring. Patients without detectable PVCs at baseline are excluded from the primary responder analysis.	Baseline to 12 months after transcatheter aortic valve replacement (TAVR)

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Pathological Conditions, Signs and Symptoms; Aortic Valve Stenosis; Arrhythmias, Cardiac; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Ticlopidine; Thienopyridines; Clopidogrel
• Other Study ID Numbers: 2024-2428; NCRC2020009 (Other Grant/Funding Number: National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No