LBBAP Data Collection Registry

Abbott Medical Devices221 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

221

Conditions

Bradycardia Sinus Node Dysfunction Heart Block Syncope Cardiomyopathies Heart Failure

Interventions

Implantation of the Tendril 2088 lead in the LBBADEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

Cardiology Consultants - Baptist Campus

Pensacola, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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. This analysis was performed on the successfully implanted population.

Time frame: 6 months after the implantation

Data from ClinicalTrials.gov

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