An observational study in Ventricular Flutter, Atrioventricular Block and Intraventricular Conduction Delay, sponsored by Baylor Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Baylor Research Institute · Observational
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.
91 studies on the registry are indexed under Bundle-Branch Block; 29 are open to participants now.
This study's enrollment of 30 is below the median of 162 across 33 observational studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →Baylor Research Institute is the lead sponsor of 219 studies on the registry; 49 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study cohort will comprise all consecutive patients who undergo permanent pacemaker placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and 12/31/2016 and will consist of up to 50 patients.
Indication for PPM including:
a. Medtronic: i. ADAPTA DR -ADDR01 ii. ADAPTA L DR-ADDRL1 iii. ADVISA MRI-A2DR01 b. St. Jude Medical: i. Zypher 5820 ii. Zypher 5826 iii. Accent pm2110 iv. Accent pm2210 v. Assurity pm2240 vi. Endurity Pm2160
Exclusion Criteria:
The study cohort will comprise all consecutive patients who undergo permanent pacemaker placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and 12/31/2016.
Device: Permanent Pacemaker Placement
Incidence of Ventricular Pacing
Incidence of Ventricular pacing post permanent pacemaker placement after TAVR as indicated by Pacemaker interrogation or remote monitoring system.
Time frame: 7-90 days
Incidence of other conduction disturbances
Freedom from documented atrioventricular block (AVB), intraventricular conduction dely (IVCD), bundle branch block (BBB) as indicated by pacemaker interrogation or remote monitoring system.
Time frame: 7-90 days
Plan to share: Yes — Data on the clinical and non-clinical risk factors will be summarized using means, standard deviations (SDs) and percentages. The Kaplan-Meier method will be used to construct a ventricular pacing free curve summarizing time-to ventricular pacing incidence in the study cohort -the competing risk of death will be accounted in the analysis.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Baylor Research Institute