Left Bundle Branch Area Pacing (LBBAP) PMCF Study
Recruiting · NCT07217392 · Interventional (participants receive a specific treatment) · Lead sponsor: Abbott Medical Devices
View the official record on ClinicalTrials.gov →Interventions studied
LBBAP lead
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
26 locations listed.
- Hopital d'adulte de la Timone - Marseille, Alpes, France
- Hopital d'adulte de la Timone - Marseille, Alpes, France
- Tan Tock Seng Hospital - Singapore, Central, Singapore
- Changi General Hospital - Singapore, Central, Singapore
- Tan Tock Seng Hospital - Singapore, Central, Singapore
- Changi General Hospital - Singapore, Central, Singapore
- Institut Jantung Negara - Kuala Lumpur, Cmalays, Malaysia
- Institut Jantung Negara - Kuala Lumpur, Cmalays, Malaysia
- Kerckhoff-Klinik gGmbH - Bad Nauheim, Hesse, Germany
- Kerckhoff-Klinik gGmbH - Bad Nauheim, Hesse, Germany
- Narayana Institute of Cardiac Sciences, Bommasandra - Bangalore, Karnakt, India
- Narayana Institute of Cardiac Sciences, Bommasandra - Bangalore, Karnakt, India
- Hospital Universitario Doce de Octubre - Madrid, Madrid, Spain
- Hospital Universitario Doce de Octubre - Madrid, Madrid, Spain
- Fortis Escorts Heart Institute - New Delhi, National Capital Territory of Delhi, India
- Vardhman Mahavir Medical College & Safdarjung Hospital - New Delhi, National Capital Territory of Delhi, India
- Fortis Escorts Heart Institute - New Delhi, National Capital Territory of Delhi, India
- Vardhman Mahavir Medical College & Safdarjung Hospital - New Delhi, National Capital Territory of Delhi, India
- Instituto Nacional de Cardiologia (INC) - Rio de Janeiro, Rio de Janeiro, Brazil
- Instituto Nacional de Cardiologia (INC) - Rio de Janeiro, Rio de Janeiro, Brazil
- Instituto do Coracao (InCor) - HCFMUSP - São Paulo, São Paulo, Brazil
- Instituto do Coracao (InCor) - HCFMUSP - São Paulo, São Paulo, Brazil
- Meenakshi Mission Hospital & Research Centre - Madurai, Tamil Nadu, India
- Meenakshi Mission Hospital & Research Centre - Madurai, Tamil Nadu, India
- Manipal Hospital E.M. Bypass - Kolkata, West Bengal, India
- Manipal Hospital E.M. Bypass - Kolkata, West Bengal, India