Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02994667
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02994667
Study Brief:
Protocol Section:
NCT02994667