The bundle of His study of electrical conduction system transmits impulses to the ventricles of the heart
- Conditions
- Health Condition 1: I442- Atrioventricular block, complete
- Registration Number
- CTRI/2020/05/025039
- Lead Sponsor
- AIG hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Scheduled for implantation of a de novo pacemaker, defibrillator, or CRT-P/D device with a pacing lead located at the His bundle according to the clinical siteâ??s routine care or upgradation of the device requiring His lead.
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
History of post-operative complex congenital heart disease
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 < 1 year
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 assessed during and after HBP/Direct LB pacing device implants respectively.Timepoint: 6 MONTHS
- Secondary Outcome Measures
Name Time Method dispalcement of lead <br/ ><br>high thresholdTimepoint: 6 months