Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)
Sponsored by Baylor Research Institute
About this trial
Last updated 5 years ago
Study ID
014-286
Status
Completed
Type
Observational
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 6 years ago
What is this trial about?
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.
What are the participation requirements?
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