LBBAP Data Collection Registry

Abbott

Status: Completed

Conditions: Bradycardia; Syncope; Heart Failure; Cardiomyopathies; Sinus Node Dysfunction; Heart Block

Treatments: Device: Implantation of the Tendril 2088 lead in the LBBA

Study type: Observational

Funder types: Industry

Identifiers

NCT05887323

ABT-CIP-10474

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Subject is ≥ 18 years of age or the legal age, whichever age is greater
3. 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

Trial design

221 participants in 1 patient group

Left Bundle Branch Area Implant

Description:

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).

Treatment:

Device: Implantation of the Tendril 2088 lead in the LBBA