Tests a heart pacing lead placed in the left bundle branch area
Tests a heart pacing lead in adults with slow heartbeat or heart rhythm problems.
Plain-language title generated from the registry record
Registry title: Left Bundle Branch Area Pacing (LBBAP) PMCF Study
Key facts
- Where
- Rio de Janeiro and São Paulo, BrazilSee the 2 sites
Where in Brazil
- Instituto Nacional de Cardiologia (INC)Rio de Janeiro, BrazilNot yet recruiting
- Instituto do Coracao (InCor) - HCFMUSPSão Paulo, BrazilNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Abbott Medical Devices
- Trial code
- NCT07217392
- Record updated
- 25 September 2026
- Original description
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.Read full original descriptionShow less
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
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.
Inclusion: 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.
Exclusion: Patient has had a previous unsuccessful attempt to place a lead in the LBB area; Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant; Patient is expected to receive a heart transplant within 6 months; Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder; Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation; Patient meets a standard contraindication for lead implant including:; 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; Patient life expectancy less than 6 months; Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study; Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.