Left Bundle Branch Area Pacing (LBBAP) PMCF Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbott Medical Devices

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

200 Participants
are divided into 1 treatment group

Sponsors and collaborators