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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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