Left Bundle Branch Area Pacing (LBBAP) PMCF Study

Recruiting now · Not applicable

Conditions studied: Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF), Cardiac Disease, Left Bundle Branch Area Pacing, Conduction System Pacing

In brief

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.

Key facts

Study ID

NCT07217392

Run by

Abbott Medical Devices

People needed

200

Starts

2025-07-24

Expected to finish

2027-04-30

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Meenakshi Mission Hospital & Research Centre — Madurai, Tamil Nadu, India (enrolling)
• Hopital d'adulte de la Timone — Marseille, Alpes, France (enrolling)
• Narayana Institute of Cardiac Sciences, Bommasandra — Bangalore, Karnakt, India (enrolling)
• Tan Tock Seng Hospital — Singapore, Central, Singapore (enrolling)
• Fortis Escorts Heart Institute — New Delhi, National Capital Territory of Delhi, India (enrolling)
• Vardhman Mahavir Medical College & Safdarjung Hospital — New Delhi, National Capital Territory of Delhi, India (enrolling)
• Instituto Nacional de Cardiologia (INC) — Rio de Janeiro, Rio de Janeiro, Brazil
• Hospital Universitario Doce de Octubre — Madrid, Madrid, Spain
• Instituto do Coracao (InCor) - HCFMUSP — São Paulo, São Paulo, Brazil
• Kerckhoff-Klinik gGmbH — Bad Nauheim, Hesse, Germany
• Manipal Hospital E.M. Bypass — Kolkata, West Bengal, India
• Institut Jantung Negara — Kuala Lumpur, Cmalays, Malaysia
• Changi General Hospital — Singapore, Central, Singapore

Full record on ClinicalTrials.gov

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