A post market registry to understand the his bundle pacing (HBP) workflow in routine practice.
- Conditions
- Health Condition 1: I440- Atrioventricular block, first degreeHealth Condition 2: I501- Left ventricular failure, unspecified
- Registration Number
- CTRI/2019/04/018796
- Lead Sponsor
- St Jude Medical India Pvt Ltd Abbott
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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.)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable