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NCT07217392From ClinicalTrials.govRecruiting

Left Bundle Branch Area Pacing (LBBAP) PMCF Study

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

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Abbott Medical Devices
Enrolment target
200
Started
24 July 2025
Main results due
30 April 2027
Study sites
15
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(15)

  • Instituto Nacional de Cardiologia (INC)

    Rio de Janeiro, Rio de Janeiro, Brazil

    Not yet recruiting

  • Instituto do Coracao (InCor) - HCFMUSP

    São Paulo, São Paulo, Brazil

    Not yet recruiting

  • Hopital d'adulte de la Timone

    Marseille, Alpes, France

    Recruiting

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim, Hesse, Germany

    Recruiting

  • Narayana Institute of Cardiac Sciences, Bommasandra

    Bangalore, Karnakt, India

    Recruiting

  • Fortis Escorts Heart Institute

    New Delhi, National Capital Territory of Delhi, India

    Recruiting

  • Vardhman Mahavir Medical College & Safdarjung Hospital

    New Delhi, National Capital Territory of Delhi, India

    Recruiting

  • Meenakshi Mission Hospital & Research Centre

    Madurai, Tamil Nadu, India

    Recruiting

  • Manipal Hospital E.M. Bypass

    Kolkata, West Bengal, India

    Recruiting

  • Az.Osp. Universitaria di Ferrara

    Cona, Emi-rom, Italy

    Recruiting

  • Institut Jantung Negara

    Kuala Lumpur, Cmalays, Malaysia

    Recruiting

  • Tan Tock Seng Hospital

    Singapore, Central, Singapore

    Recruiting

  • Changi General Hospital

    Singapore, Central, Singapore

    Recruiting

  • Hospital Universitario Doce de Octubre

    Madrid, Madrid, Spain

    Recruiting

  • Cleveland Clinic Abu Dhabi

    Abu Dhabi, ABU DBI, United Arab Emirates

    Recruiting

Showing 15 of 15 sites. 13 of the 15 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07217392. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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