LBBAP Data Collection Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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This registry is a retrospective, observational, non-controlled chart review conducted to support an indication expansion of the Tendril STS 2088 lead to include pacing/sensing in the left bundle branch area. Data from a minimum of 220 attempted subjects will be included in order to have 190 evaluable subjects in this registry. The chart review will be conducted at up to 20 participating centers worldwide.

Official Title
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Left Bundle Branch Area Pacing (LBBAP) Data Collection Registry

Conditions
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Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope, Cardiomyopathies, Heart Failure

Intervention / Treatment
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* Device: Implantation of the Tendril 2088 lead in the LBBA


Participation Criteria
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Eligibility Criteria
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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) Exclusion Criteria: 1. Subject was enrolled in another clinical trial during this data collection period that might impact the outcomes of the present registry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Left Bundle Branch Area Implant<br>Data included in this LBBAP data collection registry will be from subjects followed for 6 months (± 3 months) after attempted implant of LBBAP location. Data will be collected from previously occurring visits at pre-implant (baseline, required), implant (required), 6 months (±3 months, required), and 12 months (-2, +4months, optional). | Device: Implantation of the Tendril 2088 lead in the LBBA<br>* Conduction system pacing is achieved by delivering a pacing stimulus to the Left Bundle Branch area of the heart with Abbott's Tendril 2088 lead.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary safety endpoint evaluates freedom from LBBAP lead related serious adverse device effects (SADEs). | The primary safety endpoint evaluates a LBBAP lead related SADE rate which is an appropriate measure for safety and consistent with the primary safety endpoints used for evaluating performance of the transvenous right ventricular lead. | 6 months after the implantation | 
| The primary effectiveness endpoint evaluates the composite success rate of acceptable capture thresholds and sense amplitudes for LBBAP | The primary effectiveness endpoint evaluates the ability to pace and sense when the TendrilTM STS 2088 lead is implanted in the LBBA. | 6 months after the implantation |