Left bundle branch area pacing with Tendril STS or UltiPace leads
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
This study will try left bundle branch area pacing with the Tendril STS or UltiPace lead in adults who need pacemaker leads for bradycardia or related heart conditions to see if pacing and sensing are safe and work through six months after implant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 13 sites (Rio de Janeiro, Rio de Janeiro and 12 other locations) |
| Trial ID | NCT07217392 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years or legal age of consent) who meet guideline indications for implantation of the Tendril STS 2088TC or UltiPace LPA1231 lead in the left bundle branch area and who can comply with follow-up visits are ideal candidates.
Not a fit: Patients with prior implanted pacemaker/ICD/CRT devices, contraindications to lead implantation (for example tricuspid atresia or mechanical tricuspid valves), hypersensitivity to dexamethasone sodium phosphate, or a prior unsuccessful implant attempt are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, this approach could offer more physiologic ventricular activation than traditional right ventricular pacing and improve pacing outcomes for eligible patients.
How similar studies have performed: Other feasibility and observational series of left bundle branch area pacing have reported promising pacing parameters and more physiologic ventricular activation, but larger and longer-term comparative data are still limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rio de Janeiro, Rio de Janeiro and 12 other locations
- 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 (Not_yet_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 (Not_yet_recruiting)
- Institut Jantung Negara — Kuala Lumpur, Cmalays, Malaysia (Not_yet_recruiting)
- Tan Tock Seng Hospital — Singapore, Central, Singapore (Recruiting)
- Changi General Hospital — Singapore, Central, Singapore (Not_yet_recruiting)
- Hospital Universitario Doce de Octubre — Madrid, Madrid, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Clinical Research Scientist
- Email: trisha.satish@abbott.com
- Phone: +17472450158
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.