RecruitingACTRN12621001700820

High-Grade Atrioventricular CONDUCTion Block After Transcatheter Aortic Valve Implantation (CONDUCT TAVI)

Prospective observational study on the accuracy of predictors of high-grade atrioventricular CONDUCTion block after Transcatheter Aortic Valve Implantation (CONDUCT TAVI)

Sponsor

Royal North Shore Hospital, Northern Sydney Local Health District

Enrollment

205 participants

Start Date

Oct 26, 2021

Study Type

Observational

Conditions

High grade atrioventricular block Transcatheter Aortic Valve Implantation

Summary

Whilst high-grade atrioventricular block (HGAVB) occurs in a significant proportion of patients after transcatheter aortic valve implantation (TAVI), there are currently no sensitive and specific methods for predicting this adverse outcome. This study aims to determine the utility of both novel and previously published electrophysiological predictors of HGAVB including rapid right atrial pacing and HV interval testing before and after TAVI. This study will use implantable loop recorders to detect delayed HGAVB after TAVI.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

Age >= 18 years
Undergoing elective TAVI and have a scheduled date
Willingness to give written informed consent

Exclusion Criteria2

Permanent Pacemaker
Valve-in-valve TAVI

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Interventions

This study will investigate the factors associated with high grade atrioventricular block (HGAVB) occurring up to 24 months after Transcatheter Aortic Valve Implantation (TAVI). Electrophysiology testing (including AV Wenckebach and HV interval measurement) will be performed immediately prior to and after TAVI deployment. All patients who do not require insertion of a permanent pacemaker during their admission will receive an implantable loop recorder (which is part of the study, additional to standard of care, and will remain implanted after the study unless there is an indication for removal). Patients will be followed up at 28 days, 3 months, 6 months, 12 months and 24 months for loop recorder / pacemaker interrogation, ECG, TTE and medical review.