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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