About this trial
The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.
Eligibility criteria
Qualifiers
Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area
Are ≥ 18 years of age or age of legal consent, whichever age is greater.
Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.
Disqualifiers
the presence of tricuspid atresia
patients with mechanical tricuspid valves
patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate
Patient is currently implanted with a pacemaker, ICD, or CRT-D/P device
Trial design
Treatments tested in this trial
- LBBAP lead
Treatment groups
Locations
13Sponsors and collaborators
Abbott Medical Devices
Lead sponsor