Left bundle branch area pacing with Tendril STS or UltiPace leads

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a global, prospective, single-arm, multi-center post‑market clinical follow-up of Tendril STS (2088TC) and UltiPace (LPA1231) leads implanted for left bundle branch area pacing (LBBAP). Adult patients meeting current clinical guidelines for these leads are enrolled and receive an LBBAP lead with protocolized follow-up visits and device checks through 6 months post‑implant. The primary focus is on safety and pacing/sensing performance of the leads when placed in the left bundle branch area. Data will support a potential indication expansion for these lead models.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Clinical Research Scientist
• Email: trisha.satish@abbott.com
• Phone: +17472450158

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.