Atrioventricular Block Clinical Trial
Official title:
Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)
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.
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.
;
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 |
NCT01922518 -
Impact of Right Ventricular Pacing Determined by Electrocardiography
|
N/A | |
Completed |
NCT02282033 -
Safety and Performance Study of the Moderato System
|
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 |