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Clinical Trials in India / NCT07217392
Recruiting Not applicable

Left Bundle Branch Area Pacing (LBBAP) PMCF Study

NCT07217392 · tracked via the Priya Life Science India tracker
Sponsor
Abbott Medical Devices
Phase
Not applicable
Started
2025-07-24
Last updated
2026-09-25

Condition(s) studied

BradycardiaRight Ventricular PacingHeart FailureAtrial Fibrillation (AF)Cardiac DiseaseLeft Bundle Branch Area PacingConduction System Pacing

Investigational drug(s) / intervention(s)

LBBAP lead

LBBAP lead: The lead is bipolar, steroid-eluting, active fixation, MR Conditional, implantable pacing leads that can be placed in the right atrium, right ventricle, or left bundle branch area for pacing and sensing.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Infection Rate — 0-6 months
    Rate of Infection
  • Perforation Rate — 0-6 months
    Perforation includes cardiac perforation, septal perforation, coronary sinus dissection, pericardial effusion, and cardiac tamponade.
  • Malfunction Rate — 0-6 months
    Malfunction includes 1) mechanical lead failure including lead insulation issues, lead fracture, and other lead damage, dysfunction, helix damage or fracture; malfunction or failure; and 2) electrical abnormalities of unknown cause including sensing issues, pacing issues, loss of capture, impedance abnormality, and noise; 3) excludes infection, perforation or dislodgement caused inappropriate therapy.
  • Cardiovascular Injury Rate — 0-6 months
    Cardiovascular Injury is a safety measure specific to LBBAP leads and includes Acute coronary syndrome; Coronary artery fistula; Coronary vein fistula/injury and Septal hematoma. This parameter also includes the right bundle branch block and complete heart block (permanent).
  • Implant success rate — At the time of implant
    Rate of Implant success of LBBAP lead
  • Lead dislodgement rate — 0-6 months
    Rate of LBBAP lead dislodgement
  • Pacing threshold — 0-6 months
    Measure of minimum electrical energy required to stimulate and depolarize
  • Impedence — 0-6 months
    Measure of lead impedance
  • Sensing Amplitude — 0-6 months
    Measure of lead sensing amplitude

Trial sites (15)

FacilityCityRegionStatus
Instituto Nacional de Cardiologia (INC) Rio de Janeiro Rio de Janeiro Not Yet Recruiting
Instituto do Coracao (InCor) - HCFMUSP São Paulo São Paulo Not Yet Recruiting
Hopital d'adulte de la Timone Marseille Alpes Recruiting
Kerckhoff-Klinik gGmbH Bad Nauheim Hesse Recruiting
Narayana Institute of Cardiac Sciences, Bommasandra Bangalore Karnakt Recruiting
Fortis Escorts Heart Institute New Delhi National Capital Territory of Delhi Recruiting
Vardhman Mahavir Medical College & Safdarjung Hospital New Delhi National Capital Territory of Delhi Recruiting
Meenakshi Mission Hospital & Research Centre Madurai Tamil Nadu Recruiting
Manipal Hospital E.M. Bypass Kolkata West Bengal Recruiting
Az.Osp. Universitaria di Ferrara Cona Emi-rom Recruiting
Institut Jantung Negara Kuala Lumpur Cmalays Recruiting
Tan Tock Seng Hospital Singapore Central Recruiting
Changi General Hospital Singapore Central Recruiting
Hospital Universitario Doce de Octubre Madrid Madrid Recruiting
Cleveland Clinic Abu Dhabi Abu Dhabi ABU DBI Recruiting

More Abbott Medical Devices trials in India

ASCEND CSP IDE Study Active, not recruiting
SyncAV Post-Market Trial Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07217392 on ClinicalTrials.gov ↗ ← All trials in India