LBBAP Data Collection Registry

Completed

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

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Left Bundle Branch Area Implant	Implantation of the Tendril 2088 lead in the LBBA	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).

Primary Outcome Measures

Name	Time	Method
The Primary Safety Endpoint Evaluates Freedom From LBBAP Lead Related Serious Adverse Device Effects (SADEs).	6 months after the implantation	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.
The Primary Effectiveness Endpoint Evaluates the Composite Success Rate of Acceptable Capture Thresholds and Sense Amplitudes for LBBAP	6 months after the implantation	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.

Secondary Outcome Measures

Name	Time	Method

Locations (11): Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
National Heart Centre Singapore
🇸🇬
Singapore, Singapore
The Madras Medical Mission
🇮🇳
Chennai, Tamilnadu, India
Medanta - The Medicity Hospital
🇮🇳
Gurgaon, Nct Dlh, India
Tan Tock Seng Hospital
🇸🇬
Singapore, Singapore
Eisenhower Medical Center
🇺🇸
Rancho Mirage, California, United States
Arrhythmia Research Group
🇺🇸
Jonesboro, Arkansas, United States
Cardiology Consultants - Baptist Campus
🇺🇸
Pensacola, Florida, United States
Hopital d'adulte de la Timone
🇫🇷
Marseille, Alpes, France
North Mississippi Medical Center
🇺🇸
Tupelo, Mississippi, United States
Ospedale S.Maria della Misericordia
🇮🇹
Rovigo, Veneto, Italy