Atrioventricular Block Clinical Trial
— PPM in TAVROfficial title:
Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)
NCT number | NCT02994667 |
Other study ID # | 014-286 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | December 20, 2019 |
Verified date | January 2020 |
Source | Baylor Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 20, 2019 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Heart Hospital Baylor of Plano | Plano | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Ventricular Pacing | Incidence of Ventricular pacing post permanent pacemaker placement after TAVR as indicated by Pacemaker interrogation or remote monitoring system. | 7-90 days | |
Secondary | 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. | 7-90 days |
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