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NCT Number: NCT07217392

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) Cardiac Disease Cardiovascular Diseases Conduction System Pacing Heart Diseases Heart Failure Left Bundle Branch Area Pacing Pathologic Processes Pathological Conditions, Signs and Symptoms Right Ventricular Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Cardiologia (INC), Rio de Janeiro, Brazil

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LBBAP lead

Device

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.

Other names: CSP lead

Primary outcomes

  1. Infection Rate

    Time frame: 0-6 months

    Rate of Infection

  2. Perforation Rate

    Time frame: 0-6 months

    Perforation includes cardiac perforation, septal perforation, coronary sinus dissection, pericardial effusion, and cardiac tamponade.

  3. Malfunction Rate

    Time frame: 0-6 months

    Malfunction includes 1) mechanical lead failure including lead insulation issues, lead fracture, and other lead damage, dysfunction, helix damage or fracture; malfunction or failure; and 2) electrical abnormalities of unknown cause including sensing issues, pacing issues, loss of capture, impedance abnormality, and noise; 3) excludes infection, perforation or dislodgement caused inappropriate therapy.

  4. Cardiovascular Injury Rate

    Time frame: 0-6 months

    Cardiovascular Injury is a safety measure specific to LBBAP leads and includes Acute coronary syndrome; Coronary artery fistula; Coronary vein fistula/injury and Septal hematoma. This parameter also includes the right bundle branch block and complete heart block (permanent).

  5. Implant success rate

    Time frame: At the time of implant

    Rate of Implant success of LBBAP lead

  6. Lead dislodgement rate

    Time frame: 0-6 months

    Rate of LBBAP lead dislodgement

  7. Pacing threshold

    Time frame: 0-6 months

    Measure of minimum electrical energy required to stimulate and depolarize

  8. Impedence

    Time frame: 0-6 months

    Measure of lead impedance

  9. Sensing Amplitude

    Time frame: 0-6 months

    Measure of lead sensing amplitude

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Project Manager

CONTACT

[email protected]

+16517565602

Clinical Research Scientist

CONTACT

[email protected]

+17472450158

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: LBBAP PMCF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 16, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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