Health Condition 1: I440- Atrioventricular block, first degree Health Condition 2: I501- Left ventricular failure, unspecified
Conditions
Interventions
Intervention1: Permanent HBP lead and an Abbott pacemaker or defibrillator or CRT-P/D.: - To characterize the workflow associated with the HBP device implants and follow-up
- To quantify the clinical
Sponsors
St Jude Medical India Pvt Ltd Abbott
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet the following inclusion criteria for enrollment in the registry. 1. Scheduled for implantation of a de novo Abbott pacemaker, defibrillator, or CRT-P/D device with a pacing lead located at the His bundle according to the clinical siteâ??s routine care 2. At least 18 years of age 3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations 4. Provided written informed consent prior to any registry-related procedures
Exclusion criteria
Exclusion criteria: Subjects will be excluded from enrollment if any of the exclusion criteria is met below. 1. History of tricuspid valve repair or replacement 2. Currently participating in another clinical study with an active treatment arm and belong to the active arm 3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigatorâ??s opinion, could limit the subjectâ??s ability to participate in the registry or to comply with follow-up requirements, or impact the scientific soundness of the registry results 4. Previous failed HBP implant 5. Life expectancy of less than 6 months 6. Known contraindication for an HBP implant (i.e. ongoing infection, known inclusion of the subclavian vein, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant and follow-up characteristics will be compared with and without utilizing the EnSite Cardiac Mapping System during HBP device implants.Timepoint: Implant and 6-Month Follow-Up | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
Czech Republic, France, Germany, India, Spain, United States of America
Contacts
Public ContactDr Sumit Anand
St. Jude Medical India Pvt. Ltd.(Abbott)
Outcome results
None listed