RecruitingNot Applicable

Left Bundle Branch Area Pacing (LBBAP) PMCF Study

Brazil, France, Germany200 participantsStarted 2025-07-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Infection Rate

Timeframe: 0-6 months

Perforation Rate

Timeframe: 0-6 months

Malfunction Rate

Timeframe: 0-6 months

Cardiovascular Injury Rate

Timeframe: 0-6 months

Implant success rate

Timeframe: At the time of implant

Lead dislodgement rate

Timeframe: 0-6 months

Pacing threshold

Timeframe: 0-6 months

Impedence

Timeframe: 0-6 months

Sensing Amplitude

Timeframe: 0-6 months

Trial details

NCT IDNCT07217392

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Clinical Research Scientist

+17472450158 trisha.satish@abbott.com

View on ClinicalTrials.gov More Bradycardia trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Infection Rate

Timeframe: 0-6 months

Perforation Rate

Timeframe: 0-6 months

Malfunction Rate

Timeframe: 0-6 months

Cardiovascular Injury Rate

Timeframe: 0-6 months

Implant success rate

Timeframe: At the time of implant

Lead dislodgement rate

Timeframe: 0-6 months

Pacing threshold

Timeframe: 0-6 months

Impedence

Timeframe: 0-6 months

Sensing Amplitude

Timeframe: 0-6 months