Clinical Trials Logo
  1. Home
  2. Pacemaker Implantation
  3. NCT02994667

Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR) — PPM in TAVR  

Atrioventricular Block Clinical Trial

Official title:
Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)

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

Clinical Trial Details
NCT number NCT02994667
Study type Observational
Source Baylor Research Institute
Contact
Status Completed
Phase
Start date January 2015
Completion date December 20, 2019
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Completed NCT01019213 - Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block Phase 4
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Recruiting NCT05774262 - Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block N/A
Terminated NCT04093414 - Left Bundle Area Versus Selective His Bundle Pacing 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
Recruiting NCT05585411 - PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial N/A
Recruiting NCT05575557 - Pulmonary Artery Pressure and Right Heart Evaluation for Patients Requiring Physiological Pacing Treatment N/A
Completed NCT00187278 - Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization N/A
Recruiting NCT04595487 - LVSP vs RVP in Patients With AV Conduction Disorders N/A
Completed NCT04269733 - Risk of Pacing-induced Cardiomyopathy
Recruiting NCT03851315 - Left Bundle Branch Area Pacing in AVB Patients
Completed NCT02282033 - Safety and Performance Study of the Moderato System N/A
Completed NCT01922518 - Impact of Right Ventricular Pacing Determined by Electrocardiography N/A
Recruiting NCT04624763 - Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block 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
Completed NCT02154750 - AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals N/A