RecruitingNot ApplicableNCT07217392

Left Bundle Branch Area Pacing (LBBAP) PMCF Study

Sponsor

Abbott Medical Devices

Enrollment

200 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure Cardiac Disease Atrial Fibrillation (AF)Left Bundle Branch Area Pacing Conduction System Pacing Right Ventricular Pacing Bradycardia

Summary

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria13

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 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 life expectancy less than 6 months
Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
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.
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.

Interventions

DEVICELBBAP lead

The lead is bipolar, steroid-eluting, active fixation, MR Conditional, implantable pacing leads that can be placed in the right atrium, right ventricle, or left bundle branch area for pacing and sensing.