Status:
RECRUITING
Left Bundle Branch Area Pacing (LBBAP) PMCF Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Bradycardia
Right Ventricular Pacing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
The Left Bundle Branch Area Pacing (LBBAP) Post-Market Clinical Follow-up (PMCF) Study is a global, prospective, single-arm, multi-center trial conducted to support an indication expansion of the Tend...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07217392
Start Date
July 24 2025
End Date
April 30 2027
Last Update
October 16 2025
Active Locations (2)
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1
Fortis Escorts Heart Institute
New Delhi, National Capital Territory of Delhi, India, 110025
2
Meenakshi Mission Hospital & Research Centre
Madurai, Tamil Nadu, India, 625107