N/A
N=221
LBBAP Data Collection Registry
Bradycardia · Sinus Node Dysfunction · Heart Block · Syncope · Cardiomyopathies
Bottom Line
View on ClinicalTrials.gov: NCT05887323 ↗Enrolled (actual)
221
Serious AEs
2.3%
Results posted
Oct 2024
Primary outcome: Primary: The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs). — 220 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Implantation of the Tendril 2088 lead in the LBBA (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs). |
220 | — |
| PRIMARY The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP |
187 | — |
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.
Eligibility Criteria
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)
Exclusion Criteria
- Subject was enrolled in another clinical trial during this data collection period that might impact the outcomes of the present registry
Data sourced from ClinicalTrials.gov (NCT05887323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.