LBBAP Data Collection Registry

Left Bundle Branch Area Pacing (LBBAP) Data Collection Registry

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Heart Block; Bradycardia; Syncope; Cardiomyopathies; Sinus Node Dysfunction
• Intervention / Treatment: Device: Implantation of the Tendril 2088 lead in the LBBA

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.

• Study Type: Observational
• Enrollment (Actual): 221

Contacts and Locations

• Study Contact: Name: Jessica B Lupo; Phone Number: 8184069136; Email: Jessica.lupo@abbott.com

Study Locations

• France
  • Alpes
    • Marseille, Alpes, France, 13005
      • Hopital d'adulte de la Timone
• India
  • Nct Dlh
    • Gurgaon, Nct Dlh, India, 122001
      • Medanta - The Medicity Hospital
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600037
      • The Madras Medical Mission
• Italy
  • Veneto
    • Rovigo, Veneto, Italy, 45100
      • Ospedale S.Maria della Misericordia
• Singapore
  • Singapore, Singapore
    • Tan Tock Seng Hospital
  • Singapore, Singapore
    • National Heart Centre Singapore
• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
  • California
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center
  • Florida
    • Pensacola, Florida, United States, 32501
      • Cardiology Consultants - Baptist Campus
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-2150
      • Geisinger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with an attempted LBBA implant with Abbott's Tendril 2088 lead

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Left Bundle Branch Area Implant; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Kwangdeok Lee, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): July 12, 2023
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Arrhythmia, Sinus; Heart Block; Bradycardia; Cardiomyopathies; Syncope; Sick Sinus Syndrome
• Other Study ID Numbers: ABT-CIP-10474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes