Health Condition 1: I440- Atrioventricular block, first degree Health Condition 2: I447- Left bundle-branch block, unspecified
Conditions
Interventions
Intervention1: Tendril STS 2088 lead: Patients already implanted with the Tendril STS 2088 lead will be enrolled in this study
Control Intervention1: NIL: NIL
Sponsors
Abbott India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subject has a de novo attempted implant of the TendrilTM STS 2088 lead in the Left Bundle Branch Area on or before January 31, 2023, and subject’s medical records contain data through at least 6 months (+/- 3 months) after LBBAP implant attempt 2) Subject is = 18 years of age or the legal age, whichever age is greater 3) For sites where the governing IRB/EC has not granted a waiver of informed consent, subject has either been informed of the nature of the clinical investigation using a privacy notice or has provided a signed written informed consent, as approved by the IRB/EC (Note: This inclusion criterion is not applicable for sites where the governing IRB/EC or applicable regulation has granted a waiver of patient consent)
Exclusion criteria
Exclusion criteria: 1) Subject was enrolled in another clinical trial during this data collection period that might impact the outcomes of the present registry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint evaluates freedom from LBBAP lead related serious adverse device effects (SADEs) through 6 months post-implant attempt. The primary effectiveness endpoint evaluates the composite success rate of acceptable capture thresholds and sense amplitudes for LBBAP at 6 months post-implant.Timepoint: 6 Month | — |
Secondary
| Measure | Time frame |
|---|---|
| Capture threshold, pulse width, sense amplitude, and pacing impedance at all follow-up visitsTimepoint: 6 Month & 12 Month;Cardiovascular (CV) history and other significant medical conditionsTimepoint: 6 Month & 12 Month;Descriptive Endpoints: Demographics (if provided): sex at birth, age rangeTimepoint: 6 Month & 12 Month;Fluoroscopy time and radiation doseTimepoint: 6 Month & 12 Month;Implant procedure time: vascular access to lead fixationTimepoint: 6 Month & 12 Month;Implant success rate for LBBAP lead and reasons for unsuccessful implantTimepoint: 6 Month & 12 Month;Implant tools used (i.e., catheter, stylet, etc.): manufacturer, model#Timepoint: 6 Month & 12 Month;Indication for pacemaker or CRT-P/D implantTimepoint: 6 Month & 12 Month;LVEF, LVEDV, LVESV (if available)Timepoint: 6 Month & 12 Month;MortalityTimepoint: 6 Month & 12 Month;Number of repositioning attempts at implantTimepoint: 6 Month & 12 Month;NYHA classification (if available)Timepoint: 6 Month & 12 Month;Overall procedure time: skin-to-skinTimepoint: 6 Month & 12 Month;Procedure and device-related adverse eventsTimepoint: 6 Month & 12 Month;QRS duration and morphology (if available)Timepoint: 6 Month & 12 Month | — |
Countries
France, India, Italy, Netherlands, Singapore, United States of America
Contacts
Public ContactDr Sumit Anand
Abbott India Pvt.Ltd.
Outcome results
None listed