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

April 22, 2026 updated by: Abbott Medical Devices
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22240-006
        • Not yet recruiting
        • Instituto Nacional de Cardiologia (INC)
        • Contact:
        • Principal Investigator:
          • Rodrigo Minati Barbosa
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-000
        • Not yet recruiting
        • Instituto do Coracao (InCor) - HCFMUSP
        • Contact:
        • Principal Investigator:
          • Martino Martinelli Filho
  • France
    • Alpes
      • Marseille, Alpes, France, 13005
        • Recruiting
        • Hopital d'adulte de la Timone
        • Principal Investigator:
          • Jean-Claude Deharo
        • Contact:
  • Germany
    • Hesse
      • Bad Nauheim, Hesse, Germany, 61231
        • Not yet recruiting
        • Kerckhoff-Klinik gGmbH
        • Contact:
        • Principal Investigator:
          • Andreas Hain
  • India
    • Karnakt
      • Bangalore, Karnakt, India, 560099
        • Recruiting
        • Narayana Institute of Cardiac Sciences, Bommasandra
        • Contact:
        • Principal Investigator:
          • Kapil Kumawat
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110025
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Recruiting
        • Vardhman Mahavir Medical College & Safdarjung Hospital
        • Contact:
        • Principal Investigator:
          • Isser Hermohander Singh
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625107
        • Recruiting
        • Meenakshi Mission Hospital & Research Centre
        • Contact:
        • Principal Investigator:
          • P Jayapandian
    • West Bengal
      • Kolkata, West Bengal, India, 700099
  • Malaysia
    • Cmalays
      • Kuala Lumpur, Cmalays, Malaysia, 50400
        • Not yet recruiting
        • Institut Jantung Negara
        • Contact:
        • Principal Investigator:
          • Azlan Hussin
  • Singapore
    • Central
      • Singapore, Central, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital
        • Contact:
        • Principal Investigator:
          • David Chee Guan Foo
      • Singapore, Central, Singapore, 529889
        • Not yet recruiting
        • Changi General Hospital
        • Contact:
        • Principal Investigator:
          • Vern Hsen Tan
  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario Doce de Octubre
        • Contact:
        • Principal Investigator:
          • Luis Borrego Bernabe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area
  2. Are ≥ 18 years of age or age of legal consent, whichever age is greater.
  3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
  4. 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:

  1. Patient meets a standard contraindication for lead implant including:

    1. the presence of tricuspid atresia
    2. patients with mechanical tricuspid valves
    3. patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate
  2. Patient is currently implanted with a pacemaker, ICD, or CRT-D/P device
  3. Patient has had a previous unsuccessful attempt to place a lead in the LBB area
  4. Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
  5. Patient is expected to receive a heart transplant within 6 months
  6. Patient life expectancy less than 6 months
  7. Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
  8. Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
  9. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
  10. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left Bundle Branch Area Pacing Lead Implant
Data will be collected from patients implanted with either the Tendril STS 2088TC or UltiPace LPA1231 lead in the left bundle branch area for pacing and sensing from implant through 6 months. Leads are indicated for use in combination with a compatible pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device.
Device: LBBAP 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.
Other Names:
  • CSP lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection Rate
Time Frame: 0-6 months
Rate of Infection
0-6 months
Perforation Rate
Time Frame: 0-6 months
Perforation includes cardiac perforation, septal perforation, coronary sinus dissection, pericardial effusion, and cardiac tamponade.
0-6 months
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.
0-6 months
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).
0-6 months
Implant success rate
Time Frame: At the time of implant
Rate of Implant success of LBBAP lead
At the time of implant
Lead dislodgement rate
Time Frame: 0-6 months
Rate of LBBAP lead dislodgement
0-6 months
Pacing threshold
Time Frame: 0-6 months
Measure of minimum electrical energy required to stimulate and depolarize
0-6 months
Impedence
Time Frame: 0-6 months
Measure of lead impedance
0-6 months
Sensing Amplitude
Time Frame: 0-6 months
Measure of lead sensing amplitude
0-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

October 14, 2025

First Submitted That Met QC Criteria

October 14, 2025

First Posted (Actual)

October 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10551

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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