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

Plain Language Summary

Simplified for easier understanding

Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure to replace a narrowed heart valve without open-heart surgery. It has transformed care for older patients with severe aortic stenosis. However, one significant risk is that the procedure can disrupt the heart's electrical conduction system, sometimes causing the heart to beat dangerously slowly (high-grade atrioventricular block) and requiring implantation of a permanent pacemaker. Predicting who will develop this complication is currently unreliable. This study is testing whether specific electrical measurements taken before and immediately after TAVI — including a test where the upper heart chambers are rapidly stimulated and the electrical delay between chambers is measured (HV interval) — can predict who will go on to develop this conduction problem, even days or weeks later. Participants will also have a small loop recorder implanted under the skin to monitor heart rhythm continuously after leaving hospital. You may be eligible if you are 18 or older, are scheduled to undergo elective TAVI, and are willing to provide written informed consent. People who already have a permanent pacemaker, or who are undergoing a valve-in-valve TAVI procedure, are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.