Clinical trial NCT02994667: Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)
Official title: Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Flutter
Atrioventricular Block
Intraventricular Conduction Delay
Bundle Branch Block
Pacemaker Implantation
Keywords: Electrophysiology
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age
* Patients undergoing Transcatheter Aortic Valve Replacement
* Indication for PPM including:

  1. Persistent 3rd degree AVB
  2. Transient 3rd degree AVB
  3. New Left BBB
  4. New bifascicular block
  5. New first degree AV block
  6. Any conduction disturbance determined by the investigator to be related to the TAVR procedure 4. Patients receiving post-TAVR PPM with one of the following devices

  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:

* Pregnancy-Women of childbearing potential should have negative urine 'pregnancy test prior to enrollment
* Patients with implanted pacemaker
* Patients with implantable cardiac defibrillator
* Indication for post TAVR PPM not related to the procedure including sinus node dysfunction/sick sinus syndrome.
* Medically unable to provide consent

Primary outcomes:
measure: Incidence of Ventricular Pacing
timeFrame: 7-90 days
Secondary outcomes:
measure: Incidence of other conduction disturbances
timeFrame: 7-90 days
Other outcomes:
Locations:
city: Plano
country: United States
facility: The Heart Hospital Baylor of Plano
state: Texas
Study officials:
affiliation: The Heart Hospital Baylor of Plano
name: Brian Deville, MD
role: PRINCIPAL_INVESTIGATOR
References: