Left Bundle Branch Area Pacing (LBBAP) PMCF Study (LBBAP PMCF)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2027
  • participants needed
    200
  • sponsor
    Abbott Medical Devices
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Updated on 29 October 2025
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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.

Description

The Left Bundle Branch Area Pacing (LBBAP) Post-Market Clinical Follow-up (PMCF) Study is a global, prospective, single-arm, multi-center trial conducted to support an indication expansion of the Tendril STS (model 2088TC) and UltiPace (model LPA1231) leads to include pacing/sensing in the left bundle branch area (LBBA).

Details
Condition Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF), Cardiac Disease, Left Bundle Branch Area Pacing, Conduction System Pacing
Age 18years or above
Clinical Study IdentifierNCT07217392
SponsorAbbott Medical Devices
Last Modified on29 October 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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