Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in patients undergoing permanent pacemaker placement after TAVR.

As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients undergoing permanent pacemaker placement after TAVR.

Clinical Trial Description

Development of atrioventricular (AV) conduction system abnormalities requiring placement of a permanent pacemaker (PPM) is a known complication of transcatheter aortic valve replacement (TAVR). Male gender, pre-existing AV conduction system abnormalities, transient AV block intra-procedurally, and use of a self-expanding valve have all been associated with increased risk of AV block and need for permanent pacemaker placement. Persistent AV conduction abnormalities have been documented in approximately 15% of patients who receive an Edwards Sapien valve, with 4% requiring permanent pacemaker placement. 22-28% of patients who receive a CoreValve require permanent pacemaker placement in some studies. In one study, 78% of patients who underwent His bundle electrogram assessment during CoreValve placement had transient or persistent AV conduction system abnormalities during the procedure.

Pacemakers placed at The Heart Hospital Baylor Plano are produced by two manufactures: Medtronic, Inc. and St. Jude Medical, Inc. Each of these manufacturers have pacemakers with algorithms designed to minimize right ventricular pacing. Medtronic's algorithm is referred to as "MVP" (Managed Ventricular Pacing), and St. Jude Medical's algorithm is referred to as "VIP" (Ventricular Intrinsic Preference). Each of these techniques purports to reduce unnecessary right ventricular (RV) pacing through a novel pacemaker algorithm. Both manufacturers' pacemaker programmers and remote monitoring systems allow for demonstration of the percentage of ventricular pacing performed by the device.

The Investigators propose to assess the 90 day- ventricular pacing, atrioventricular block (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate histogram incidence in those patients who undergo pacemaker implantation due to elevated risk (or occurrence of) high-grade AV block after TAVR. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT02994667
Study type Observational
Source Baylor Research Institute
Status Completed
Start date January 2015
Completion date December 20, 2019

See also
  Status Clinical Trial Phase
Completed NCT01019213 - Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block Phase 4
Recruiting NCT04093414 - Left Bundle Area Versus Selective His Bundle Pacing N/A
Not yet recruiting NCT04624763 - Protection on Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block N/A
Withdrawn NCT00559143 - Biventricular Alternative Pacing Phase 4
Recruiting NCT04730921 - Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block) N/A
Completed NCT00187278 - Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization N/A
Recruiting NCT04269733 - Risk of Pacing-induced Cardiomyopathy
Recruiting NCT03851315 - Left Bundle Branch Area Pacing in AVB Patients
Recruiting NCT01922518 - Impact of Right Ventricular Pacing Determined by Electrocardiography N/A
Completed NCT02282033 - Safety and Performance Study of the Moderato System N/A
Completed NCT03231826 - Arrhythmias in Post-Myocardial Infarction Patients
Not yet recruiting NCT04437901 - COVIDAR - Arrhythmias in COVID-19
Recruiting NCT01717469 - Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias Phase 4
Active, not recruiting NCT02154750 - AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals N/A
Completed NCT02462941 - Analysis of Adenosine on Sinus and Atrioventricular Nodal Conduction in the Pediatric Transplanted Heart Phase 1
Completed NCT00627328 - The Atrial High Rate Episodes in Pacemaker Patients N/A
Active, not recruiting NCT02837445 - Moderato System: A Double-Blind Randomized Trial Ver 1.1 N/A
Not yet recruiting NCT03024047 - Cohort Description of Younger With AV-block N/A
Terminated NCT01798043 - Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance N/A
Recruiting NCT04544345 - Impact of Atrio-ventricular Optimization With His Bundle Pacing on Treatment of Atrio-ventricular Dromotropathy N/A