CompletedNot Applicable

LBBAP Data Collection Registry

United States221 participantsStarted 2023-04-25

Plain-language summary

The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject has a de novo attempted implant of the TendrilTM STS 2088 lead in the Left Bundle Branch Area on or before January 31, 2023 and subject's medical records contain data through at least 6 months (+/- 3 months) after LBBAP implant attempt
✓. Subject is ≥ 18 years of age or the legal age, whichever age is greater
✓. For sites where the governing IRB/EC has not granted a waiver of informed consent, subject has either been informed of the nature of the clinical investigation using a privacy notice or has provided a signed written informed consent, as approved by the IRB/EC (Note: This inclusion criterion is not applicable for sites where the governing IRB/EC or applicable regulation has granted a waiver of patient consent)

What they're measuring

The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs).

Timeframe: 6 months after the implantation

The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP

Timeframe: 6 months after the implantation

Trial details

NCT IDNCT05887323

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-11

Results submitted2024-07-08

View on ClinicalTrials.gov More Bradycardia trials