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

Completed

Conditions studied: Ventricular Flutter, Atrioventricular Block, Intraventricular Conduction Delay, Bundle Branch Block, Pacemaker Implantation

In brief

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.

Key facts

Study ID

NCT02994667

Run by

Baylor Research Institute

People needed

30

Starts

2015-01-01

Expected to finish

2019-12-20

Last updated by the study team

2020-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients > 18 years of age
• Patients undergoing Transcatheter Aortic Valve Replacement
• Indication for PPM including:
• Persistent 3rd degree AVB
• Transient 3rd degree AVB
• New Left BBB
• New bifascicular block
• New first degree AV block
• 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

You may not qualify if…

• 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

Where it is running

• The Heart Hospital Baylor of Plano — Plano, Texas, United States

Full record on ClinicalTrials.gov

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