NCT05887323

LBBAP Data Collection Registry

Left Bundle Branch Area Pacing (LBBAP) Data Collection Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 221 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bradycardia
• Sinus Node Dysfunction
• Heart Block
• Syncope
• Cardiomyopathies
• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-25
• Primary completion: 2023-07-11
• Completion: 2023-07-11
• First posted: 2023-06-02
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

11 sites across 5 countries: United States, France, India, Italy, Singapore

Regulatory

• FDA-regulated device study